Philips North America Llc
195 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Philips North America Llc and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-11-15FDA-DeviceClass IIDigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export digital radiographic images.
Potential for units suspended on the ceiling to fail and fall.
- 2023-11-15FDA-DeviceClass IIDigitalDiagnost 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.
- 2023-11-15FDA-DeviceClass IICombiDiagnost R90, Radiography and Fluoroscopy (R/F) system
Potential for units suspended on the ceiling to fail and fall.
- 2023-10-11FDA-DeviceClass IIEarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863359
A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
- 2023-10-11FDA-DeviceClass IIEarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380
A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
- 2023-09-27FDA-DeviceClass IIPatient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Product Number: 866389; (2) Patient Information Center iX Expand Product Number: 866390; (3) PIC iX Essentials Product Number: 867093; (4) PIC iX Essentials Expand Product Number: 867154
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 patient monitoring. Potential for a delay in the detection of a change or deterioration in the condition of one or more patients
- 2023-07-05FDA-DeviceClass IIDigitalDiagnost C90, Model No. 712034 and 712035
There is a software login in issue that may prevent the user from logging in.
- 2023-06-07FDA-DeviceClass IIEarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 863380
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.
- 2023-06-07FDA-DeviceClass IIEARLYVUE 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.
- 2023-05-24FDA-DeviceClass IISpectral 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: pain, muscle or ligament sprain, abrasion, laceration, contusion, fracture, loss of function, and joint dislocation.
- 2023-05-10FDA-DeviceClass IIPhilips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radiography and fluoroscopy (R/F) system
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 cable breaks, the user may not be able to initiate table tilting movements or braking
- 2023-04-19FDA-DeviceClass IIDigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
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 normal wear and tear; as a result there is a potential that the Ceiling Suspension of the DigitalDiagnost C50 system may descend inadvertently if power to the system is interrupted, and may result in injuries to patients and users
- 2023-04-19FDA-DeviceClass IIPhilips 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 normal wear and tear; as a result there is a potential that the Ceiling Suspension of the DigitalDiagnost C50 system may descend inadvertently if power to the system is interrupted, and may result in injuries to patients and users
- 2023-04-19FDA-DeviceClass IIProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110
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 smoke emitting from the cabinet, or hear a popping sound coming from the cabinet.
- 2023-04-19FDA-DeviceClass IICombiDiagnost 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 smoke emitting from the cabinet, or hear a popping sound coming from the cabinet.
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