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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 461–480 of 1137 recalls

Spectral CT 7500 (Philips) – Software Functionality (2023)

Multiple software issues that affect device functionality.

FDANov 30, 2023Nationwide• Philips North America Llc

BrightView X Camera (Philips) – Scan Motion Gap (2023)

Laceration Risk

While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.

FDANov 30, 2023Nationwide• Philips North America

Patient Information Center (Philips) – Push Notification Failure (2023)

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.

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FDANov 28, 2023Nationwide• Philips North America

CareEvent Monitor (Philips) – Push Notification Failure (2023)

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

Trilogy Evo Respirator – Missing Contraindication Statement (2023)

The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg. The AVAPS feature is contraindicated for patients less than 10 kg. Potential harms if devices are used on contraindicated patients include barotrauma, hypoventilation/hypercapnia, and rebreathing of excessive CO2.

FDANov 27, 2023Nationwide• Philips Respironics, Inc.

Panorama MR System (Philips) – Helium Pressure Buildup (2023)

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

Azurion Systems (Philips) – ceiling mount collision risk (2023)

Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or potential sterility issues due to the cover becoming loose

FDANov 3, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands