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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

327

Past Year

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 261–280 of 327 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 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.

FDA

1...12 131415 16 17

Page 14 of 17Next

Nov 18, 2020

Nationwide

• 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 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 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 Charging Station, Product #: 989803191021 - Prod...

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 Module Charger, Product #: 989803191031 - Produc...

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: 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

Philips North America, LLC: Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - P...

Philips has identified a Philips SureSigns VM1 monitor in the possession of a clinical user that was not intended for commercial distribution and for which Philips does not have records regarding its manufacture. Philips is therefore removing this device from distribution.

FDAMay 19, 2020Nationwide• Philips North America, LLC

Philips North America, LLC: Philips HeartStart MRx Monitor/Defibrillators Model numb...

HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections

FDAApr 27, 2020Nationwide• Philips North America, LLC

Philips North America, LLC: ProxiDiagnost N90, UDI 706100

The thermo switches in the three-phase transformer, which normally aid in powering down the System Power Distribution Unit, may be incorrectly installed and not working. If the transformer overheats due to a first failure and the thermo switch is not activated, the device may begin to generate smoke.

FDAApr 23, 2020Nationwide• Philips North America, LLC

Philips North America, LLC: Philips HeartStart XL Monitor/Defibrillators Model number...

HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections

FDAApr 21, 2020Nationwide• Philips North America, LLC

Philips North America, LLC: Philips Sterilizable Defibrillator Internal Paddles - Int...

Internal Paddles may wear over time and may not be safe or ready for use, unless the directions in the Instructions for Use (IFU) to perform routine operational checks are followed. The instructions for use rely on these checks rather than specifying a maximum number of sterilization cycles to determine when the paddles should be discarded. A damaged Internal Paddle may not be able to deliver therapy.

FDAApr 20, 2020Nationwide• Philips North America, LLC

Philips North America, LLC: Magnetic Resonance Imaging Diagnostic Device accessory - ...

The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex.

FDAApr 13, 2020Nationwide• Philips North America, LLC