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…
Read the official notice →- Date
- 2023-09-27
- Country
- United States
- Brand
- Philips
- Product
- Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Product Number: 866389;…
- Classification
- Class II
- Units
- Nationwide Foreign: Austria Bahrain Belgium Canada Czech Republic Denmark…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Philips recalls
- 2023-11-15
USPhilips 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 → - 2023-08-16
- 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 →
Other drugs & medical recalls in the United States
- 2023-09-27
- US
GE Medical Systems Information Technologies Inc recalls Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX…
A diode on the power supply of the Prucka 3 Amplifier used with CardioLab/ComboLab systems could reach elevated temperatures and fail, then power off and become inoperable.
FDA · DeviceGE Medical Systems Information Technologies IncDistribution was made to CA, CO, FL, GA, IL, IN, KY, MA, NC, NJ, OH, OR, PA,…Official notice → - US
Tytek Medical Inc recalls TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from…
Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location
FDA · DeviceTytek Medical IncOH, SC, VA Foreign: Country Australia Denmark Finland Germany Hong Kong/China…Official notice → - US
Randox Laboratories Ltd. recalls Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet…
- US
Encore Medical, LP recalls DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to…
FDA · DeviceEncore Medical, LPUS: AL, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NY, OH,…Official notice → - US
Stryker Corporation recalls Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement witha constant high…
Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the ACM system and…
FDA · DeviceStryker CorporationNationwide Foreign: Austria Belgium Canada France Germany Hong Kong Italy…Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049
4.5" Iris Scissors, Sterile, Curved (DYNJ04049) are being recalled due to the potential of the tip protector to fall off. The sharp tip of the scissors could compromise the sterile barrier system by puncturing large…
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldWorldwide distribution: US (nationwide) and OUS (foreign) countries of:…Official notice →