Philips Medical Systems Nederland recalls
59 official recalls and safety alerts involving Philips Medical Systems Nederland since 2022-02, from 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 Medical Systems Nederland or the relevant agency.
- 2026-08-19
USPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version…
Two software related issues: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead…
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224,…
Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of…
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional…
Firmware issue potentially leading to loss of geometry movements.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Canada, Algeria,…Official notice → - 2026-08-12
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
- 2026-06-24
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034 for…
Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection
- 2026-06-10
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with…
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without…
- 2026-06-03
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222),…
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Canada,…Official notice → - 2026-05-27
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12…
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Domestic: Nationwide; International: Canada, Algeria, Argentina, Australia,…Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and…
Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Nationwide distribution. International distribution to Albania, Algeria,…Official notice → - 2026-05-20
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230),…
Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the country of Canada.Official notice → - 2026-04-22
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to…
Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - 2026-04-08
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Vue Motion V12. Product Number: 1017979.
Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Algeria, Andorra,…Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Domestic: Nationwide Distribution; International: Afghanistan, Albania,…Official notice → - 2026-02-18
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.X,…
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Afghanistan,…Official notice → - 2026-01-28
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion system; Software Version Number: R3.1;
Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content and/or loss of data.…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.International distribution in the countries of AE, AR, AT, AZ, BE, BG, BH, BR,…Official notice → - 2026-01-21
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and…
Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Afghanistan,…Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model…
Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Albania, Algeria,…Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD10F; Model Number: 722002;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - 2025-12-03
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;
The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Domestic: AL, AR, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MD, MN, MO, NM, NY,…Official notice → - 2025-10-29
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Distribution US states of MO and TX; Belgium, Canada, Fiji, Germany, India,…Official notice → - 2025-10-08
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842,…
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Albania, Algeria,…Official notice → - 2025-10-01
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638,…
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Albania, Algeria,…Official notice → - 2025-09-17
- US
Philips Medical Systems Nederland B.V. recalls IntelliSpace Cardiovascular, Software 8.0.0.4.
Software issue that results in the display of outdated information.
FDA · DevicePhilips Medical Systems Nederland B.V.US Nationwide distribution in the states of GA, NC & TX.Official notice → - 2025-09-10
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model…
Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide distribution in the states of AL, AZ, CA, DC, FL,…Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with…
Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - 2025-08-06
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper…
Potential for temporary loss of imaging (X-ray) functionality due to software issue.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide and the countries of Algeria, Argentina, Australia,…Official notice → - 2025-07-30
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M20. Fluoroscopic X-Ray System.
Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution: US (nationwide) to states of: CA, CO, DC, DE, FL, IL,…Official notice → - 2025-06-18
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7)…
A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Afghanistan,…Official notice → - 2025-05-21
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Intera 1.5T Master/Nova, Model Number: 781106;
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…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.US: Nationwide Distribution International: Algeria, Andorra, Argentina,…Official notice → - 2025-05-14
- US
Philips Medical Systems Nederland B.V. recalls IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.
FDA · DevicePhilips Medical Systems Nederland B.V.Domestic: Nationwide Distribution International: Australia, Austria, Belgium,…Official notice → - 2025-04-30
- US
Philips Medical Systems Nederland B.V. recalls Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as…
Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.
- 2025-03-19
- US
Philips Medical Systems Nederland B.V. recalls Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.
- 2025-03-12
- US
Philips Medical Systems Nederland B.V. recalls Philips IntelliSpace Cardiovascular software, Model 830089.
Study data is not able to be archived, copied, or exported with the cardiovascular software version.
FDA · DevicePhilips Medical Systems Nederland B.V.US Nationwide distribution in the states of AK, AL, AZ, CA, CT, FL, GA, IA,…Official notice → - 2025-02-26
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.
Possibility of the patient falling from the table related to the mattress used on the patient table.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldiwde distribution - US Nationwide and the countries of Afghanistan,…Official notice → - 2025-02-12
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 3 M12 System Code: (1) 722063 (2) 722221
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Canada,…Official notice → - 2024-12-18
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura…
Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit is not installed in a timely manner. Root cause is under investigation, but the recall reason is listed as for systems…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Nationwide distribution. International distribution to Albania, Algeria,…Official notice → - 2024-11-20
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Zenition 50, Model Number: 718096
Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Albania, Algeria,…Official notice → - 2024-09-25
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7…
Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Nationwide, Canada and Worldwide: Albania Algeria Argentina Armenia Australia…Official notice → - 2024-09-11
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers…
The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide distribution.Official notice → - 2024-08-28
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010,…
A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide distribution in the states of IL and OR. The…Official notice → - 2024-08-14
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for…
Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Afghanistan,…Official notice → - 2024-06-05
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of…
Potential for pressure wave data synchronization from two devices may not be correct.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide in the states of CA, IN, OR and the…Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100.
When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Domestic: OK International: India, Spain, U.A.E.Official notice → - 2024-02-28
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive…
Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide distribution in the states of NY, PA,…Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used…
Dual In-Line Memory Modules (DIMMs) may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide Distribution: US nationwide including states of: AL, AK, AR, AZ, CA,…Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected…
Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide Distribution: US nationwide including states of: AL, AK, AR, AZ, CA,…Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected…
Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide distribution.Official notice → - 2024-02-07
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
Loss of connectivity between the FlexArm and the Table due to a software issue related to the date/time format. This connection issue leads to a loss of movement of the arm or table.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide distribution in the states of CO, FL, IL, MS, NV and…Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
Loss of connectivity between the FlexArm and the Table due to a software issue.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide distribution in the states of CO, FL, IL, MS, NV and…Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12…
System may exhibit a loss of imaging functionality and data due to an issue which can cause the system to continuously restart. If the issue occurs during a procedure, there may be a delay and/or abortion of the…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide distribution.Official notice → - 2023-12-27
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion 7…
Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide and the countries of Albania, Algeria, Argentina,…Official notice → - 2023-09-20
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems
A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible.
- 2023-09-13
- US
Philips Medical Systems Nederland B.V. recalls Allura Xper series
A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
- 2023-09-06
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems
Loss of availability of the wireless foot switch during procedures.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2023-08-09
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M20. X-ray Image guided Therapy System.
The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2023-06-07
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1)…
Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available there will be a sudden interruption of the procedure
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Nationwide Foreign: Algeria Argentina Armenia Australia Austria Bahrain…Official notice → - 2023-04-26
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide distribution.Official notice → - 2022-05-11
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion systems with software release R1.x
In the Azurion system, the user can add a new study to a patient by selecting the option Add Study . The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.US Nationwide and Worldwide DistributionOfficial notice → - 2022-02-23
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Zenition 50, Model #718096
Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Domestic distribution to AZ CA FL GA HI IL KS KY MA MD ME MI MN MS NC NE NJ NV…Official notice →