Philips recalls
100 official recalls and safety alerts involving Philips since 2021-10, from EU Safety Gate, FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Philips or the relevant agency.
- 2026-10-07
USPhilips North America recalls Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 782103 (3.0T), 4. 781271 (3.0T CX); Software…
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction…
FDA · DevicePhilips North AmericaWorldwide distribution - Nationwide and the countries of Algeria, Argentina,…Official notice →- US
Philips North America Llc recalls Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving additional…
- 2026-09-30
- US
Philips North America Llc recalls Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of Albania, Algeria,…Official notice → - 2026-09-23
- US
Philips North America recalls Philips PIC iX Essentials REF:867093
Due to software malfunction, patient information system may freeze and become unresponsive.
FDA · DevicePhilips North AmericaWorldwide - US Nationwide distribution including in the states and territories…Official notice → - 2026-09-09
- US
Philips North America Llc recalls Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software…
Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
- 2026-08-26
- US
Philips North America Llc recalls Cardiac Workstation 5000. Product Number: 860439.
Device will intermittently provide inaccurate data related to native heart rate.
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2026-07-01
- US
Philips North America Llc recalls Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz,…
Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system.
FDA · DevicePhilips North America LlcUS Nationwide distribution in the states of AZ, CA, CO, IN, MA, MI, MN, PA,…Official notice → - US
Philips North America Llc recalls Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and The countries of AE, AT, AU, BE,…Official notice → - 2026-06-17
- US
Philips North America Llc recalls DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.
System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events.
- 2026-05-06
- US
Philips North America recalls Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE…
FDA · DevicePhilips North AmericaWorldwide - US Nationwide and the countries of Argentina, Australia,…Official notice → - 2026-02-18
- US
Philips North America Llc recalls Brilliance iCT; Product Code (REF): 728306;
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners…
FDA · DevicePhilips North America LlcWorldwide - US Nationwide distribution in the states of AL, AR, CA, CO, CT,…Official notice → - 2026-02-04
- US
Philips North America recalls SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
FDA · DevicePhilips North AmericaWorldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA,…Official notice → - 2026-01-28
- US
Philips North America recalls Patient Information Center iX; Software Version Number: 4.5.0
A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.
FDA · DevicePhilips North AmericaWorldwide distribution - US Nationwide and the countries of Austria, Belgium,…Official notice → - 2026-01-14
- US
Philips North America Llc recalls Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.
It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly.
- 2025-12-17
- US
Philips North America recalls Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance…
- 2025-12-10
- US
Philips North America Llc recalls CT 5300; Software Version Number: 4.5, 5.0, 5.1;
If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems…
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of Albania, Algeria,…Official notice → - US
Philips North America Llc recalls IntelliVue MP90. Product Number: M8010A.
Potential issue where the IntelliVue monitors did not alarm.
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of Afghanistan,…Official notice → - 2025-10-22
- US
Philips North America recalls Cardiac Workstation 5000; Model Number: 860439;
Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
FDA · DevicePhilips North AmericaUS Nationwide distribution in the states of CA, IA, TN, TX, VA.Official notice → - 2025-10-01
- US
Philips North America Llc recalls Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - 2025-08-06
- US
Philips North America recalls Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
FDA · DevicePhilips North AmericaWorldwide distribution - US Nationwide and the countries of Albania, Algeria,…Official notice → - 2025-07-02
- US
Philips North America Llc recalls Spectral CT. Computed tomography X-ray system.
Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT…
FDA · DevicePhilips North America LlcDomestic: AZ, CA, CO, FL, GA, HI, IN, KY, MA, MD, MN, NY, OH, OR, PA, TX, VT,…Official notice → - 2025-06-18
- US
Philips North America recalls Intera 1.5T Achieva Nova-Dual Product Number: 781173;
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the…
FDA · DevicePhilips North AmericaWorldwide - US Nationwide distribution in the states of AZ, CA, DE, MA, MI,…Official notice → - 2025-05-28
- US
Philips North America Llc recalls Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of Andorra,…Official notice → - 2025-05-14
- US
Philips North America Llc recalls Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm…
Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of AE, AL, AO, AR,…Official notice → - 2025-04-30
- US
Philips North America Llc recalls Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.
FDA · DevicePhilips North America LlcWorldwide distribution: US (Nationwide); and OUS (Foreign) to countries of:…Official notice → - US
Philips North America Llc recalls Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, interventional…
A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
- 2025-04-23
- US
Philips North America Llc recalls Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.
Potential for collimator to fall as a result of incorrect installation.
FDA · DevicePhilips North America LlcWorldwide - US Nationwide distribution in the states of AK, FL, KS, MS, NH,…Official notice → - 2025-02-12
- US
Philips North America Llc recalls IntelliVue Patient Monitor MX400. Model Number: 866060
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
FDA · DevicePhilips North America LlcUS distribution to Florida, North Carolina, and Oregan. International…Official notice → - 2024-12-25
- US
Philips North America Llc recalls Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
The following four issues are included: 1. Certain Channel Settings may result in an Access Point preventing a connected client device from roaming to another Access Point potentially causing the client device to…
- 2024-12-11
- US
Philips North America Llc recalls Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
Potential for a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a collision with the operator or with the needle placed inside the patient, and an incorrect patient ID…
FDA · DevicePhilips North America LlcWorldwide - US Nationwide distribution in the states of AR, AZ, CA, FL, GA,…Official notice → - 2024-12-04
- US
Philips North America Llc recalls dS Breast 16ch 1.5T
Potential safety issue where a patient may be harmed while preparing for or during a scan.
- 2024-10-16
- US
Philips North America recalls Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1
During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Protocol) lease can expire on the MX40. If the DHCP lease expires while the device is offline, upon reconnecting with the PIC…
- US
Philips North America Llc recalls IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows:…
Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP2 were not enabled in these devices.…
FDA · DevicePhilips North America LlcForeign Only: Denmark France Germany Japan United KingdomOfficial notice → - 2024-10-09
- US
Philips North America Llc recalls DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips…
If the DIVA touch display generates touch inputs without user interaction, due to possibility of the erroneous acknowledgement of a patient alarm, there is a potential for a delay in the detection of a change in a…
FDA · DevicePhilips North America LlcWorldwide - US Nationwide distribution in the states of CA, IL, ME, NC, NJ,…Official notice → - US
Philips North America recalls IntelliVue G7m Anesthesia Gas Module, Product Number 866173
The 866173 lntelliVue G7m Anesthesia Gas Modules could have a component issue that may trigger an interruption of the gas measurement. This issue concerns the G7m's sample gas pump which could stop working, producing a…
- 2024-10-02
- US
Philips North America recalls IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 (Model Number…
During a production process, Philips became aware of one IntelliVue power supply with a broken ground bolt upon disconnection of the ground cable from the equipotential ground connector. Loss of electrical grounding…
- US
Philips North America Llc recalls Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal…
Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May…
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - 2024-08-14
- US
Philips North America Llc recalls IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicated for use by health…
Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for software-version N.x. In the…
FDA · DevicePhilips North America LlcNationwide Foreign: Australia Austria Bangladesh Brazil Canada Chile China…Official notice → - 2024-07-10
- US
Philips North America Llc recalls Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.
Potential for inaccurate fetal heart rate measurements when monitoring multiples.
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of AD, AE, AR, AT,…Official notice → - 2024-07-03
- US
Philips North America Llc recalls SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model…
Potential for coils to heat up and harm patients (burn).
FDA · DevicePhilips North America LlcWorldwide distribution: US (Nationwide) and OUS (Foreign): Afghanistan,…Official notice → - 2024-06-12
- US
Philips North America Llc recalls HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number:…
Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2024-05-29
- US
Philips North America Llc recalls Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728144
Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the…
- US
Philips North America Llc recalls Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of Austria, Belgium,…Official notice → - 2024-05-22
- US
Philips North America Llc recalls Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a…
Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation
FDA · DevicePhilips North America LlcWorldwide - US Nationwide distribution in the states of CA, KS, MS, NH and the…Official notice → - US
Philips North America Llc recalls Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.
Event Catalog information does not save when copied and transferred from one unit to another.
FDA · DevicePhilips North America LlcWorldwide - US Nationwide distribution in the states of CA, FL, GA, IA, MA,…Official notice → - 2024-05-08
- US
Philips North America Llc recalls The Oncology Essentials Package of the Spectral CT imaging system.
Potential for third party oncology marking laser to be reflected off the gantry cover surface, which can potentially lead to misdiagnosis and subsequent incorrect treatment.
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide in the states of AZ, HI, MN, VT, WV and…Official notice → - 2024-05-01
- US
Philips North America Llc recalls Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS): 1. APC (Schneider Electric IT Corporation) 120V…
Possible failure of Uninterruptable Power Supply (UPS) devices supporting the Patient Information Center (PIC) iX system, potential for the associated PIC iX system to shut down due to the lack of power. may lead to…
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of Argentina, Aruba,…Official notice → - 2024-04-24
- US
Philips North America Llc recalls Ingenia 1.5T S, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of Albania, Algeria,…Official notice → - 2024-04-17
- US
Philips North America recalls PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to V4.5.1.41989-Intended to produce…
Patient tabletop moved out to the home position during scan initialization, may cause operator/bystander staying by the rear of the table to collide with the moved tabletop and be injured
FDA · DevicePhilips North AmericaNationwide including Puerto Rico Foreign: Albania Argentina Australia Austria…Official notice → - 2024-04-03
- US
Philips North America recalls CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X
It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode.
- 2024-02-21
- US
Philips North America recalls ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150
Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patients radiography (RAD) images when starting the next patient scan while the previous patient image export is still processing. If…
FDA · DevicePhilips North AmericaNationwide Foreign: Australia Germany India Italy Malaysia Panama ThailandOfficial notice → - 2024-02-14
- US
Philips North America recalls Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be attracted to MRI systems if the wheels are in the magnetic field.
FDA · DevicePhilips North AmericaWorldwide - US Nationwide distribution in the states of FL and NY. The…Official notice → - US
Philips North America recalls BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791 453560279811 453560279801;…
Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, contusion, laceration, and/or fracture to the patient's lower limbs,…
FDA · DevicePhilips North AmericaDomestic distribution nationwide. International distribution worldwide.Official notice → - 2024-02-07
- US
Philips North America recalls Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin…
- 2024-01-31
- US
Philips North America recalls Achieva 3.0T, Model No. 781177
An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the…
FDA · DevicePhilips North AmericaWorldwide - US Nationwide distribution in the states of AR, CO, IL, MD, MS,…Official notice → - 2024-01-24
- US
Philips North America recalls (1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expand, Model No. 866390 (3) PIC iX Hardware, Model…
Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition.
FDA · DevicePhilips North AmericaWorldwide distribution: US (Nationwide) to states of: CA, GA, IA, MA, MI, MN,…Official notice → - US
Philips North America Llc recalls Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
Multiple software issues that affect device functionality.
FDA · DevicePhilips North America LlcDomestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium,…Official notice → - US
Philips North America recalls Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871
If the Patient Interface Monitor (PIM) Cable is plugged/unplugged frequently as part of daily operation, the connector and wire may disconnect from the welding point, which may result in intermittent loss of the ECG…
FDA · DevicePhilips North AmericaDomestic distribution to the following states: AL CA CO FL GA HI IL IN KS KY…Official notice → - 2024-01-17
- US
Philips North America recalls (1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)
The sealed magnet will experience uncontrolled shutdown known as Loss-of-Field (LoF) if the magnet loses cryo-cooling (e.g. caused by a power outage on site.)
FDA · DevicePhilips North AmericaDomestic distribution to the following states and territories: CA DE FL GA IL…Official notice → - US
Philips North America recalls BrightView X, Gamma Camera, Product Code 882478
While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients…
FDA · DevicePhilips North AmericaDomestic distribution nationwide. Foreign distribution worldwide.Official notice → - 2023-12-27
- US
Philips North America Llc recalls The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional…
Three software issues affecting incorrect image display, error interpreting patient images due to image reporting, and patient exposure to incorrect image/function during clinical use.
FDA · DevicePhilips North America LlcDomestic: AL, AR, AZ, CA, FL, GA, HI, IL, IN, KY, LA, MD, ME, MI, MS, NC, NJ,…Official notice → - 2023-12-20
- US
Philips North America Llc recalls Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical…
Firm was informed of an event in which the structural integrity of the MR system components failed due to unintended excessive pressure buildup of helium gas during a magnet quench. If the system is unable to contain…
FDA · DevicePhilips North America LlcDomestic distribution to AL AZ CA CO DE FL GA IA IL IN KS KY LA MA MD MI MO NE…Official notice → - 2023-11-29
- US
Philips North America Llc recalls SmartPath to dStream for 1.5T
Potential component failure in the Gradient Coil could product smoke and/or fire.
FDA · DevicePhilips North America LlcDomestic: Nationwide Distribution; Foreign: Albania, Andorra, Argentina,…Official notice → - 2023-11-22
- US
Philips North America recalls Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the desired needle position. This…
- US
Philips North America recalls Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be restarted.
- US
Philips North America Llc recalls Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation oncology and…
For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect…
FDA · DevicePhilips North America LlcNationwide Foreign: Austria Belgium Canada China Estonia France Germany…Official notice → - 2023-11-17
SE
EURemote control (Philips) · 3986GR08
The solders in the product have an excessive concentration of lead (measured value up to 64 % by weight).Lead poses a risk to the environment. The product does not comply with the requirements of the Directive on the…
- 2023-11-15
- US
Philips North America Llc recalls DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images.
Potential for units suspended on the ceiling to fail and fall.
- US
Philips North America recalls Allura Xper IGTS Fixed Systems
Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer…
FDA · DevicePhilips North AmericaUnited States Territories of Puerto Rico, Guam, and Virgin IslandsOfficial notice → - 2023-10-11
- US
Philips North America Llc recalls EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product…
A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
FDA · DevicePhilips North America LlcWorldwide - US Nationwide distribution in the states of MA, MI. The country of…Official notice → - 2023-09-27
- US
Philips North America Llc recalls Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Product Number:…
Patient Information Center (PIC iX) Release 4.x Surveillance Crash Caused by Intel Graphics Driver Error-with a blank screen and subsequently require a manual reboot of the hardware to restart and continue central…
FDA · DevicePhilips North America LlcNationwide Foreign: Austria Bahrain Belgium Canada Czech Republic Denmark…Official notice → - 2023-08-16
- US
Philips North America recalls Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and…
- US
Philips North America recalls Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.
- 2023-08-09
- US
Philips North America recalls Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146
Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud…
FDA · DevicePhilips North AmericaNationwide Foreign: China Algeria Argentina Australia Austria Azerbaijan…Official notice → - 2023-07-05
- US
Philips North America Llc recalls DigitalDiagnost C90, Model No. 712034 and 712035
There is a software login in issue that may prevent the user from logging in.
FDA · DevicePhilips North America LlcDistribution in US: AZ, GA, IN, IA, MN, NE, NH, OH, TX OUS distribution to…Official notice → - 2023-06-07
- US
Philips North America Llc recalls EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359
EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an inaccurate CO2 measurement which may lead to a failure to recognize a change in patient condition.
FDA · DevicePhilips North America LlcNationwide Foreign: Belgium Brazil Canada Denmark Germany Guam Hong Kong…Official notice → - 2023-05-24
- US
Philips North America recalls ProxiDiagnost N90 R.1.0
Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA).
- US
Philips North America recalls Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813
Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operator's foot and injury
FDA · DevicePhilips North AmericaWorldwide - US Nationwide distribution in the states of AR, CA, FL, IL, IN,…Official notice → - US
Philips North America Llc recalls Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333
Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operators foot. If foot or leg entrapment occurs while pressing Unload Pedal, the risk to operators may include:…
FDA · DevicePhilips North America LlcWorldwide - US Nationwide distribution including in the states of States: AZ,…Official notice → - 2023-05-10
- US
Philips North America Llc recalls Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radiography and…
Potential table stop due to a broken tabletop cable: On the ProxiDiagnost N90 table there is a cable located under the tabletop that is covered by a plastic sleeve which can crack and damage the cable. If the tabletop…
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide including Puerto Rico and the countries…Official notice → - 2023-04-19
- US
Philips North America Llc recalls Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201
If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside of the telescopic carriage will unavoidably decay through…
FDA · DevicePhilips North America LlcNationwide including Puerto Rico and Virgin Islands Foreign: ARGENTINA…Official notice → - US
Philips North America Llc recalls CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031
If the system experiences an overvoltage / power surge it can cause a short circuit condition within the Main- cabinet. If this issue occurs, the user may experience an electrical fire within the cabinet, see or smell…
- 2023-01-18
- US
Philips North America Llc recalls Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631
Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical intervention to remove the broken tip from the neonate patient. Philips has decided to discontinue the distribution of…
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2022-12-14
- US
Philips North America Llc recalls Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144
Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
- 2022-10-12
- US
Philips North America Llc recalls MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
Device may intermittently fail to produce audio. Turning the unit off and on does not resolve the issue; disconnecting and reconnecting to AC power does not reliably resolve the issue.
FDA · DevicePhilips North America LlcDomestic distribution to AL AZ CA CO FL GA ID IL IN LA MA MI MN NC NE NJ OH PA…Official notice → - 2022-09-07
- US
Philips North America Llc recalls DigitalDiagnost C50 1.1
Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of the image on the first examination due to an issue in…
- 2022-05-18
- US
Philips North America Llc recalls Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3. For visualization and analysis of…
When a Neonatal patient is admitted, the Non-Invasive Blood Pressure is not set to Neonatal mode on the Philips Xperflex Cardio FC2010 patient monitor. If the NIBP is not set to Neonatal, the cuff inflation pressure…
FDA · DevicePhilips North America LlcDevices were distributed to the following US states: FL, ID, NJ, OK, SC and…Official notice → - 2022-04-20
- US
Philips North America, LLC recalls The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following product model #s:…
Update to instructions for use regarding the cleaning and disinfection process for the reusable probes.
FDA · DevicePhilips North America, LLCWorldwide distribution: US (nationwide) Including Puerto Rico and OUS…Official notice → - 2022-04-13
- US
Philips North America LLC recalls Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS
There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. The gel may fold onto itself resulting in reduced surface area or gel on the pad, or it may…
FDA · DevicePhilips North America LLCWorldwide distribution. US Nationwide including Puerto Rico and Guam, Germany,…Official notice → - US
Philips North America Llc recalls Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063,…
Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the current run and instead show an image processed in a previous run. The image shown could be from the same patient or from…
- 2022-03-16
- US
Philips North America Llc recalls Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird chiller WITHOUT an…
Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room,…
FDA · DevicePhilips North America LlcUS Nationwide Foreign: Argentina Austria Bangladesh Brazil Chile China Denmark…Official notice → - 2022-02-09
- US
Philips North America Llc recalls eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version…
eCareManager (eCM) Sentry Score software not approved for use
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the country of Australia.Official notice → - 2022-01-26
- US
Philips North America Llc recalls Infa-Therm Transport Mattress, Reference Number 989805616831 1015
After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new…
- 2022-01-19
- US
Philips North America Llc recalls Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional Fluoroscopic X-ray System . Model Number:…
Wireless foot switch connection issues causing interruption of Fluoroscopy and exposure
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of Canada, Australia,…Official notice → - US
Philips North America Llc recalls Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2…
(1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not established; (2) Emergency stop recovery problem-warm restart is not…
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide distribution in the state of WA and the…Official notice → - 2021-12-29
- US
Philips North America Llc recalls Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging…
Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mounted on the Monitor Ceiling Suspension (MCS) can come loose, the Extra monitors might disengage from the Mounting Ceiling…
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide distribution in the states of DC, GA,…Official notice → - 2021-12-15
- US
Philips North America Llc recalls BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718075
Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result…
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of Afghanistan,…Official notice → - 2021-12-01
- US
Philips North America Llc recalls Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64 System Number: 882471 Continuous CT (CCT) is a CT or…
Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient, operator, bystander, or…
FDA · DevicePhilips North America LlcUS (nationwide) distribution to states of: CA, ME, TX and OUS (Foreign) to…Official notice → - 2021-11-17
- US
Philips North America Llc recalls Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078,…
When the user presses or releases both the APC (accept) button and the Float Tabletop (panning) button at the same time, the geometry may stop reacting on movement requests (table lock-up) and X-ray imaging becomes…
FDA · DevicePhilips North America LlcDomestic distribution nationwide. International distribution worldwide.Official notice → - 2021-10-20
- US
Philips North America LLC recalls Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
Customers were not notified of previous recalls associated with various defibrillator models.
FDA · DevicePhilips North America LLCU.S.: CA, CT, FL, GA, IN, MI, MO, NJ, NY, OH, TX, and WA. International…Official notice →