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Philips Medical Systems North America Co. Phillips

Philips Medical Systems North America Co. Phillips Recalls

All product recalls associated with Philips Medical Systems North America Co. Phillips.

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Recall Summary

Total Recalls

416

Past Year

Class I (Serious)

Most Recent

Oct 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 261–280 of 416 recalls

Philips Medical Systems North America Co. Phillips: Essenta DR is a digital multifunctional X-ray systems, su...

When a patient is selected in the patient list and examination tab pressed with background query running at the same time, the wrong patient may be selected.

FDAAug 15, 2008Nationwide• Philips Medical Systems North America Co. Phillips

Philips Medical Systems: Philips Diagnostic Ultrasound System, Model HD3. Product...

The system has a software defect that affects the display of Estimated Fetal Weight (EFW) Growth Percentile result values.

FDAAug 12, 2008PR• Philips Medical Systems

Philips Medical Systems: Philips HeartStart FRx Defibrillator, Automated External ...

The affected device may not deliver appropriate defibrillation therapy.

FDA

1...12 131415 16...21

Page 14 of 21Next

Aug 7, 2008

Nationwide

• Philips Medical Systems

Philips Medical Systems: Philips Telemonitoring System Software (M3811B) used with...

Software: If Weight Limits edited, values will return to default values that were deleted

FDAJul 22, 2008Nationwide• Philips Medical Systems

Philips Medical Systems: HeartStarMRtX Defibrillator/Monitor Models: M3535A/M3536A...

Defective internal memory cards may exhibit one or more of the following behaviors: "Device repeatedly restarts approximately every 20 seconds "Slow device start-up of approximately 15 seconds or more. During this time, the MRx displays either a blank screen or the Philips HeartStart MRx Start-up screen prior to displaying the selected mode of operation (i.e. Monitor, AED, Pacing or Manual Defib mode). "Internal Memory Failure INOP message when attempting to print an event from the Data Management screen. "When printing from the Data Management screen, a patients Event Summary prints with some clinical events missing.

FDAJul 14, 2008Nationwide• Philips Medical Systems

Philips Medical Systems North America Co. Phillips: The Philips EasyDiagnost Eleva with DRF. Philips Medical...

Potential for bright artifacts to appear on the patient image from a previous exposure.

FDAJul 9, 2008AZ, CA, FL +2 more• Philips Medical Systems North America Co. Phillips

Philips Medical Systems North America Co. Phillips: Motorized Height Ceiling Suspensions (MCS) and motorized ...

Monitor ceiling carriage may separate from the monitor ceiling suspension.

FDAJun 26, 2008Nationwide• Philips Medical Systems North America Co. Phillips

Philips And Neusoft Medical Systems Co., Ltd.: NeuViz Dual series computed Tomography Scanner System, X-...

Potential for R-host box and components inside to be detached of its mounting during the gantry rotor rotation. There is a potential for components to be damaged inside the system gantry and for the internal components to be expelled from the system gantry and injure the patient, operator, bystander or service people.

FDAJun 23, 2008CO, FL, IN +5 more• Philips And Neusoft Medical Systems Co., Ltd.

Philips Medical Systems: Biopsy Guide Starter Kits L9-5 used with the Philips HD3 ...

HD3 Biopsy Guide Kits do not contain adequate labeling instructions for safe and effective use.

FDAMay 29, 2008AR, CO, DE +8 more• Philips Medical Systems

Philips Medical Systems: Biopsy Guide Starter Kits C7-3 used with the Philips HD3 ...

HD3 Biopsy Guide Kits do not contain adequate labeling instructions for safe and effective use.

FDAMay 29, 2008AR, CO, DE +8 more• Philips Medical Systems

Philips Medical Systems: Biopsy Guide Starter Kits C5-2 used with the Philips HD3 ...

HD3 Biopsy Guide Kits do not contain adequate labeling instructions for safe and effective use.

FDAMay 29, 2008AR, CO, DE +8 more• Philips Medical Systems

Philips Medical Systems North America Co. Phillips: General X-Ray System types with Digital Spot Imaging (DSI...

X-ray images may be stored in the wrong patient file or corrupted, images from two different patients may be combined in one patient's folder or may be combined on one image (corrupted).

FDAMay 23, 2008Nationwide• Philips Medical Systems North America Co. Phillips

Philips Medical Systems (Cleveland) Inc: GEMINI PET/CT System, a diagnostic imaging system for fix...

The reason for this inspection is to determine if the Spindle Block Servo Controllers on the CT subsystem of potentially affected GEMINI PET/CT systems are susceptible to premature failure.

Class IIModerate

FDAMay 1, 2008AL, AZ, CA +32 more• Philips Medical Systems (Cleveland) Inc

Philips Medical Systems (Cleveland) Inc: GEMINI PET/CT System, a diagnostic imaging system for fix...

The reason for this inspection is to determine if the Spindle Block Servo Controllers on the CT subsystem of potentially affected GEMINI PET/CT systems are susceptible to premature failure.

FDAMay 1, 2008AL, AZ, CA +32 more• Philips Medical Systems (Cleveland) Inc

Philips Medical Systems: Phillips Medical Systems, SureSigns VS3 Vital Signs Monit...

Some users of SureSigns VS3 Signs Monitor may have assumed that the SpO2 Non-Pulsatile and SpO2 No Sensor technical alarms were enabled when the SureSigns VS3 Vital Signs Monitor was not in Interval non-invasive blood pressure (NBP) mode. These alarms are only enabled when interval NBP mode is selected. If when monitoring SpO2, the clinician does not notice when the sensor is no longer attached, the patient is not being monitored through Spo2.This could result in delay or lack of needed therapy. The labeling provided with the monitor did not fully describe this feature.

FDAApr 30, 2008Nationwide• Philips Medical Systems

Philips Medical Systems: Philips defibrillator, model M5066A. Sold in the US by P...

Buttons Sticking - The On/Off and Shock buttons on the front panel of the device may stick in place when pressed and fail to respond to the button press, causing a delay in the delivery of a defibrillation shock when the system advises a shock.

FDAApr 30, 2008Nationwide• Philips Medical Systems

Philips Medical Systems: Laerdal "HeartStart Defibrillator", model M5067A, under L...

FDAApr 30, 2008Nationwide• Philips Medical Systems

Philips Medical Systems: Philips "HeartStart Home" defibrillator, model M5068A and...

FDAApr 30, 2008Nationwide• Philips Medical Systems

Philips Medical Systems North America Co. Phillips: NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner ...

An issue associated with the "Timed Scan" application was found. The system does not wait for the programmed time interval and starts the x-ray after selection of the scan button when certain criteria is met.

FDAApr 10, 2008Nationwide• Philips Medical Systems North America Co. Phillips

Philips Medical Systems North America Co. Phillips: Essenta DR - digital multifunctional x-ray system (applic...

Bright artifacts may appear on a patient image from a previous exposure, which might lead to a misdiagnosis.

FDAApr 8, 2008Nationwide• Philips Medical Systems North America Co. Phillips