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Philips North America Llc

Philips North America Llc Recalls

All product recalls associated with Philips North America Llc.

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Recall Summary

Total Recalls

1000

Past Year

272

Class I (Serious)

Most Recent

Dec 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 681–700 of 1137 recalls

Philips North America Llc: IntelliVue MX40 Patient Monitor, Model Number: 865350 (US...

Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices

FDAFeb 2, 2021Nationwide• Philips North America Llc

Philips Ultrasound Inc: Philips EPIQ Diagnostic Ultrasound System, Models EPIQ El...

Control panel arm assembly could have missing or loose screws where undue force, pressure or weight is applied, the control panel mechanism can fail and break off.

FDADec 24, 2020Nationwide• Philips Ultrasound Inc

Philips North America: PHILIPS Incisive Computed tomography X-ray system Incisiv...

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

1...33 343536 37...57

Page 35 of 57Next

FDA

Dec 24, 2020

Nationwide

• Philips North America

Philips Ultrasound Inc: Philips EPIQ Diagnostic Ultrasound System; Model Numbers:...

The manufacturer discovered an issue associated with the EPIQ Image Boost with xPlane and Color Flow or Doppler while using the X8-2t TEE Transducer. If Image Boost is enabled the color box shows flow visualization not accurately represent the fluid flow. Similarly, if Image Boost is enabled, both CW and PW Doppler traces will not accurately represent the fluid flow.

FDADec 16, 2020AL, CA, CO +35 more• Philips Ultrasound Inc

PHILIPS HOME HEALTHCARE SOLUTION: ProxiDiagnost N90 Image-intensified fluoroscopic x-ray sy...

After the user selects the Lock-in command, the kV and mA values are not locked immediately and can adjust if the collimator shutter position is changed directly after the Lock-in command.

FDADec 8, 2020Nationwide• PHILIPS HOME HEALTHCARE SOLUTION

Philips North America, LLC: Emission Computed Tomography System Image Process System ...

A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient.

FDANov 19, 2020Nationwide• Philips North America, LLC

Philips North America Llc: Philips IntelliVue X2 Multi measurement Server: M3002A (8...

Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the patient.

FDANov 18, 2020Nationwide• Philips North America Llc

Philips North America Llc: Philips IntelliVue MP2 Patient Monitors (865040) - Produc...

Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the patient.

FDANov 18, 2020Nationwide• Philips North America Llc

Philips Ultrasound Inc: All EPIQ and Affiniti Ultrasound systems. Model numbers -...

The manufacturer has determined that with certain uncommon workflows there is potential for incorrect patient data to be displayed and saved into an exam. The issue(s) manifest differently for different versions of software.

FDAOct 27, 2020Nationwide• Philips Ultrasound Inc

Philips North America, LLC: Philips Sterilizable Defibrillator Paddles, Switched Inte...

The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator Paddles may not detect one failure mode for the Switched Internal Defibrillator Paddles. Philips has created an addendum to the IFU, that includes a test for the switched paddles only, which will detect this failure mode.

FDASep 14, 2020Nationwide• Philips North America, LLC

Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany: CombiDiagnost R90 Software Version R1.0 and R1.1

Philips has become aware of a software issue, where the kV and mA values are not locked immediately but change when the collimator shutter position is changed directly after the Lock-In command. This software issue leads to an over or under exposed image.

FDAJul 22, 2020Nationwide• Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany

Philips North America, LLC: Philips HeartStart MRx, Monitor/Defibrillators with model...

The therapy switch may fail, resulting in the device exhibiting the following behaviors: the device may not perform the selected function, the therapy knob may not change to the energy setting selected, or the device may deliver a shock with an energy level different from the setting selected by the user. These device behaviors could result in a delay in therapy or a failure to deliver the intended therapy.

FDAJul 16, 2020Nationwide• Philips North America, LLC

Philips North America, LLC: IntelliVue MX700 patient monitor, model no. 865241

Some Intellivue MX700/MX800 Patient Monitors were delivered with defective power supplies. The defective power supplies might energize the metal parts of monitor if the grounding instructions were not followed, and may also cause the monitor to stop operating or prevent it from being switched on.

FDAJun 30, 2020CA, HI, MA +2 more• Philips North America, LLC

Philips North America, LLC: IntelliVue MX800 patient monitor, model no. 865240

FDAJun 30, 2020CA, HI, MA +2 more• Philips North America, LLC

Philips North America, LLC: IntelliVue G7m Anesthesia Gas Module, Model no. 866173, F...

The device may experience an interruption of gas measurement due to a firmware issue, ceasing measurement and display of gas levels and generating one or more technical or INOP alarms.

FDAJun 25, 2020Nationwide• Philips North America, LLC

Philips North America, LLC: Phillips Module Charger, Product #: 989803191031 - Produc...

A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. When the battery is inserted into a charger bay, the LED indicatory lights solid red and the battery will not charge. This may result from poor electrical contact between the battery and charger.

FDAJun 18, 2020IN• Philips North America, LLC

Philips North America, LLC: Phillips 3.7V Rechargeable Li-Polymer Battery, Product #:...

FDAJun 18, 2020IN• Philips North America, LLC

Philips North America, LLC: Phillips Charging Station, Product #: 989803191021 - Prod...

FDAJun 18, 2020IN• Philips North America, LLC

Philips North America, LLC: Philips M3015A Microstream CO2 Extension Model No. 86239...

Affected M3015A extensions are incompatible with the lntelliVue X3 Patient Monitor (Model No. 867030) and lntelliVue MMX multi-measurement server (Model No. 867036).If they are connected to a host monitor, communication with the X3 or MMX could be disrupted, resulting in a loss of monitoring on the host monitor.

FDAJun 8, 2020Nationwide• Philips North America, LLC

Philips North America, LLC: EasyDiagnost Eleva DRF, model no. 706050 - Product Usage:...

Thermo switches in the main power supply for the system may be incorrectly installed, resulting in a malfunction.

FDAJun 2, 2020Nationwide• Philips North America, LLC