Philips North America recall records

126 reported ongoing

126 records in this archive. Latest source date Jul 31, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm 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.

Class IIReported ongoing

Distribution: United States Territories of Puerto Rico, Guam, and Virgin Islands

Official source for BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems.
FDA device enforcement

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.

Class IIReported ongoing

Distribution: United States Territories of Puerto Rico, Guam, and Virgin Islands

Official source for Integris-Allura IGTS Fixed Systems
FDA device enforcement

Allura Xper 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.

Class IIReported ongoing

Distribution: United States Territories of Puerto Rico, Guam, and Virgin Islands

Official source for Allura Xper IGTS Fixed Systems
FDA device enforcement

Azurion 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.

Class IIReported ongoing

Distribution: United States Territories of Puerto Rico, Guam, and Virgin Islands

Official source for Azurion IGTS Fixed Systems
FDA device enforcement

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.

Class IIReported ongoing

Distribution: United States Territories of Puerto Rico, Guam, and Virgin Islands

Official source for Veradius Unity Mobile Surgery C-arm
FDA device enforcement

Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)

During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and does not impact the functionality of the s...

Class IIReported ongoing

Distribution: US Nationwide. Global Distribution.

Official source for Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (Sma...
FDA device enforcement

Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106

During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and does not impact the functionality of the s...

Class IIReported ongoing

Distribution: US Nationwide. Global Distribution.

Official source for Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
FDA device enforcement

MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)

During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and does not impact the functionality of the s...

Class IIReported ongoing

Distribution: US Nationwide. Global Distribution.

Official source for MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
FDA device enforcement

Incisive CT-Computed Tomography X-Ray System Model: 728143

Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system wil...

Class IIReported ongoing

Distribution: Nationwide Foreign: China Algeria Argentina Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Czech Republic Ec...

Official source for Incisive CT-Computed Tomography X-Ray System Model: 728143
FDA device enforcement

Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146

Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system wil...

Class IIReported ongoing

Distribution: Nationwide Foreign: China Algeria Argentina Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Czech Republic Ec...

Official source for Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146
FDA device enforcement

Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148

Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system wil...

Class IIReported ongoing

Distribution: Nationwide Foreign: China Algeria Argentina Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Czech Republic Ec...

Official source for Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148
FDA device enforcement

Incisive CT Plus-Computed Tomography X-Ray System Model: 728149

Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system wil...

Class IIReported ongoing

Distribution: Nationwide Foreign: China Algeria Argentina Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Czech Republic Ec...

Official source for Incisive CT Plus-Computed Tomography X-Ray System Model: 728149
FDA device enforcement

Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1

During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Protocol) lease can expire on the MX40. If the DHCP lease expires while the device is offline, upon reconnecting with the PIC iX, a new IP address will be assigned t...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution.

Official source for Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Pro...
FDA device enforcement

Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814

Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operator's foot and injury

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of AR, CA, FL, IL, IN, MI, MO, NY, TN, TX, VT and the countries of Australia, Chile, Costa Rica, Czech Republic, Dominican, ...

Official source for Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814
FDA device enforcement

Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813

Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operator's foot and injury

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of AR, CA, FL, IL, IN, MI, MO, NY, TN, TX, VT and the countries of Australia, Chile, Costa Rica, Czech Republic, Dominican, ...

Official source for Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813
FDA device enforcement

ProxiDiagnost N90 R.1.0

Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA).

Class IIReported ongoing

Distribution: US Nationwide

Official source for ProxiDiagnost N90 R.1.0

Reasons in these listed records

  • 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.
  • The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.
  • During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and does not impact the functionality of the system and/or the Smo...
  • Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down

These examples come from this result page and are not a ranking of every recall reason.

Checking Philips North America

Is there a recall on philips north america right now?

This archive contains 126 records, including 126 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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