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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

326

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 61–80 of 326 recalls

MR 5300 (Philips) – Image Alignment Error (2025)

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Moderate

FDAMay 13, 2025Nationwide• Philips North America Llc

Ingenia 1.5T S (Philips) – Image Alignment Error (2025)

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Moderate

FDAMay 13, 2025Nationwide• Philips North America Llc

Ingenia Ambition S (Philips) – Image Alignment Error (2025)

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Moderate

FDA

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Page 4 of 17Next

May 13, 2025

Nationwide

• Philips North America Llc

Ingenia Elition X (Philips) – Image Alignment Error (2025)

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Moderate

FDAMay 13, 2025Nationwide• Philips North America Llc

Ingenia 1.5T (Philips) – Image Alignment Error (2025)

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Moderate

FDAMay 13, 2025Nationwide• Philips North America Llc

Ingenia 1.5T CX (Philips) – Image Alignment Error (2025)

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Moderate

FDAMay 13, 2025Nationwide• Philips North America Llc

SmartPath 1.5T (Philips) – Image Alignment Error (2025)

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Moderate

FDAMay 13, 2025Nationwide• Philips North America Llc

SmartPath Ingenia Elition X (Philips) – Image Alignment Error (2025)

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Moderate

FDAMay 13, 2025Nationwide• Philips North America Llc

Microstream Advance CO2 Filter (Philips) – Adapter Disconnection Risk (2025)

Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.

Moderate

FDAApr 7, 2025Nationwide• Philips North America Llc

Brilliance CT Big Bore (Philips) – Gantry Motion Risk (2025)

Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.

Moderate

FDAApr 1, 2025Nationwide• Philips North America Llc

Philips DXR System (Philips) – collimator fall risk (2025)

Potential for collimator to fall as a result of incorrect installation.

Moderate

FDAMar 10, 2025Nationwide• Philips North America Llc

Veradius Unity (Philips) – Radiation Emission Risk (2025)

A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.

Moderate

FDAFeb 25, 2025Nationwide• Philips North America Llc

Zenition 70 (Philips) – Radiation Emission Risk (2025)

A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.

Moderate

FDAFeb 25, 2025Nationwide• Philips North America Llc

Zenition 50 (Philips) – Radiation Emission Risk (2025)

A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.

Moderate

FDAFeb 25, 2025Nationwide• Philips North America Llc

IntelliVue Patient Monitor (Philips) – alarm failure (2025)

Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

Moderate

FDAJan 15, 2025FL, NC• Philips North America Llc

IntelliBridge EC10 Module (Philips) – alarm failure (2025)

Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

Moderate

FDAJan 15, 2025FL, NC• Philips North America Llc

IntelliVue Patient Monitor (Philips) – Alarm Failure (2025)

Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

Moderate

FDAJan 15, 2025FL, NC• Philips North America Llc

Philips Smart-Hopping AP (Philips) – Channel Setting Problem (2024)

The following four issues are included: 1. Certain Channel Settings may result in an Access Point preventing a connected client device from roaming to another Access Point potentially causing the client device to appear to drop out from the network. 2. if the Access Point experiences a disconnection from the Access Point Controller exceeding 4 minutes, the Access Point may not transition through the desired state to all for clean reconnection of the client radio link. 3. Potential to experience higher than expected data dropouts, device disassociations/reassociations for their wireless clients, and frequent "Loss of AP" alerts. 4. Potential for the Smart-hopping Access Point is affected by a software issue where the Access Point will resent after 82.85 days when the frame counter reaches its limit. This causes the latest synchronization check to fail and potential for loss of patient data.

Moderate

FDANov 20, 2024Nationwide• Philips North America Llc

Spectral CT Scanner (Philips) – Procedure Box Risk (2024)

Potential for a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a collision with the operator or with the needle placed inside the patient, and an incorrect patient ID software issue that may lead to misdiagnosis.

Moderate

FDANov 16, 2024Nationwide• Philips North America Llc

dS Breast 7ch 3.0T (Philips) – Patient Safety Risk (2024)

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Moderate

FDANov 4, 2024Nationwide• Philips North America Llc