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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

532

Past Year

77

Class I (Serious)

0

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 221–240 of 532 recalls

Philips North America Llc: Spectral CT 7500, Software Version 5.0.0.X. Computed Tom...

Multiple software issues that affect device functionality.

FDANov 30, 2023Nationwide• Philips North America Llc

Philips North America: (1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, M...

Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition.

FDANov 28, 2023Nationwide• Philips North America

Philips North America: (1) Patient Information Center iX, Model No. 866389 (2) P...

Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition.

1...10 111213 14...27

Page 12 of 27Next

Nov 28, 2023

Nationwide

• Philips North America

Philips North America Llc: Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model ...

Firm was informed of an event in which the structural integrity of the MR system components failed due to unintended excessive pressure buildup of helium gas during a magnet quench. If the system is unable to contain the pressured helium gas due to an unforeseen blockage in the system, risks to patients and/or operators that may lead to injury or death include chemical exposure (i.e. helium gas) that may expand to surrounding rooms, contusion caused by debris, and asphyxia.

FDANov 17, 2023AL, AZ, CA +31 more• Philips North America Llc

Philips North America Llc: Intera 1.5T

Potential component failure in the Gradient Coil could product smoke and/or fire.

FDAOct 23, 2023Nationwide• Philips North America Llc

Philips North America Llc: Achieva 1.5T Conversion

Potential component failure in the Gradient Coil could product smoke and/or fire.

FDAOct 23, 2023Nationwide• Philips North America Llc

Philips North America Llc: Ingenia 1.5T CX

Potential component failure in the Gradient Coil could product smoke and/or fire.

FDAOct 23, 2023Nationwide• Philips North America Llc

Philips North America Llc: Achieva 1.5T Initial System

Potential component failure in the Gradient Coil could product smoke and/or fire.

FDAOct 23, 2023Nationwide• Philips North America Llc

Philips North America Llc: Intera 1.5T Power/Pulsar

Potential component failure in the Gradient Coil could product smoke and/or fire.

FDAOct 23, 2023Nationwide• Philips North America Llc

Philips North America Llc: Achieva 1.5T

Potential component failure in the Gradient Coil could product smoke and/or fire.

FDAOct 23, 2023Nationwide• Philips North America Llc

Philips North America Llc: SmartPath to dStream for 1.5T

Potential component failure in the Gradient Coil could product smoke and/or fire.

FDAOct 23, 2023Nationwide• Philips North America Llc

Philips North America Llc: Big Bore RT with software version V4.8.0.10421- Model: 72...

For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment.

FDAOct 9, 2023Nationwide• Philips North America Llc

Philips North America: Spectral CT on Rails, Software Version 5.1.0, Model Numbe...

When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be restarted.

FDAOct 9, 2023Nationwide• Philips North America

Philips North America Llc: Brilliance CT Big Bore Oncology with software version V4....

For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment.

FDAOct 9, 2023Nationwide• Philips North America Llc

Philips North America: Spectral CT on Rails, Software Version 5.1.0, Model Numbe...

This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the desired needle position. This issue could result in the gantry moving to a location the operator does not expect. If this occurs, it presents a risk that the scan could occur at an incorrect location, or that the unintended motion of the gantry could cause a collision with the user or needle. The other part of the recall involves a software crash when the CCT foot pedal is activated (as described in RES ID93363).

FDAOct 9, 2023Nationwide• Philips North America

Philips North America Llc: Brilliance CT Big Bore with software version V4.8.0.10421...

For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment.

FDAOct 9, 2023Nationwide• Philips North America Llc

Philips North America: Veradius Unity Mobile Surgery C-arm

Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.

FDAOct 4, 2023Nationwide• Philips North America

Philips North America: BV Endura, BV Pulsera Philips Image Guided Therapy-System...

Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.

FDAOct 4, 2023Nationwide• Philips North America

Philips North America: Integris-Allura IGTS Fixed Systems

Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.

FDAOct 4, 2023Nationwide• Philips North America

Philips North America: Zenition 50 & 70 Mobile Surgery C-arm

Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.

FDAOct 4, 2023Nationwide• Philips North America