Philips North America recalls

56 recent recalls on record for Philips North America in connected official government data as of October 22, 2026 at 12:00 PM UTC.

Models with recalls

Achieva 1 (1)Achieva 3 (1)Achieva XR (1)Cardiac Workstation 5000 (1)Cardiac Workstation 7000 (1)DigitalDiagnost C90 Flex/Value/Chest/ER (1)Evolution upgrade 1 (2)Ingenia 1 (2)Ingenia 3 (2)Ingenia Ambition S and Ingenia Ambition X (2)Ingenia Blue Seal SE and Blue Seal XE (1)Ingenia Elition S and Ingenia Elition X (2)MR 5300 (1)MR 5300 Model Number (REF) (1)MR 7700 (1)MR 7700 and Upgrade to MR 7700 (1)Name (Model Number) (1)Philips Achieva 1 (2)Philips Achieva 3 (1)Philips Avalon Fetal Monitor (2)Philips Brilliance (1)Philips Brilliance CT 64 (1)Philips Evolution Upgrade 1 (1)Philips Evolution upgrade 3 (1)Philips IQon Spectral CT Product Codes (1)Philips Ingenia 1 (2)Philips Ingenia 3 (2)Philips Ingenia Ambition S with MR Elastography (MRE) (1)Philips Ingenia Ambition X with MR Elastography (MRE) (1)Philips Ingenia Elition S with MR Elastography (MRE) (1)Philips Ingenia Elition X with MR Elastography (MRE) (1)Philips Ingenuity CT Product Codes (1)Philips MR 7700 with MR Elastography (MRE) (1)Philips Medical Systems Technologies Ltd (1)Philips PIC iX Essentials REF (1)Philips Patient Information Center iX REF (1)Philips SmartPath to Ingenia Elition X with MR Elastography (MRE) (1)Philips SmartPath to dStream for 1 (1)Philips SmartPath to dStream for 3 (1)Philips SmartPath to dStream for XR and 3 (1)Philips Telemetry Monitor 5500 1 (1)Philips Upgrade to MR 7700 with MR Elastography (MRE) (1)SmartPath to MR 7700 (1)SmartPath to dStream for 1 (2)Upgrade dStream (1)Upgrade to MR 7700 (1)

All Philips North America recalls

FDA Class II · Medical device · October 7, 2026

Evolution upgrade 1 recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Official ID Z-3318-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Upgrade to MR 7700 recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Official ID Z-3317-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Upgrade dStream recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Official ID Z-3316-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

SmartPath to MR 7700 recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Official ID Z-3315-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

SmartPath to dStream for 1 recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Official ID Z-3314-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

MR 7700 recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Official ID Z-3313-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

MR 5300 recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Official ID Z-3312-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Ingenia Elition S and Ingenia Elition X recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Official ID Z-3311-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Ingenia Ambition S and Ingenia Ambition X recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Official ID Z-3310-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Ingenia 3 recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Official ID Z-3309-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Ingenia 1 recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Official ID Z-3308-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Ingenia Blue Seal SE and Blue Seal XE recall — Philips North America

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …

Official ID Z-3307-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Philips Medical Systems Technologies Ltd recall — Philips North America Llc

The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in t…

Official ID Z-3155-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

SmartPath to dStream for 1 recall — Philips North America Llc

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…

Official ID Z-3243-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

MR 7700 and Upgrade to MR 7700 recall — Philips North America Llc

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…

Official ID Z-3242-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

MR 5300 Model Number (REF) recall — Philips North America Llc

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…

Official ID Z-3241-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Name (Model Number) recall — Philips North America Llc

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…

Official ID Z-3240-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Ingenia Elition S and Ingenia Elition X recall — Philips North America Llc

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…

Official ID Z-3239-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Ingenia 3 recall — Philips North America Llc

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…

Official ID Z-3238-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Ingenia Ambition S and Ingenia Ambition X recall — Philips North America Llc

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…

Official ID Z-3237-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Ingenia 1 recall — Philips North America Llc

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…

Official ID Z-3236-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Evolution upgrade 1 recall — Philips North America Llc

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…

Official ID Z-3235-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Achieva XR recall — Philips North America Llc

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…

Official ID Z-3234-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Achieva 3 recall — Philips North America Llc

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…

Official ID Z-3233-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Achieva 1 recall — Philips North America Llc

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…

Official ID Z-3232-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Philips PIC iX Essentials REF recall — Philips North America

Due to software malfunction, patient information system may freeze and become unresponsive.

Official ID Z-3142-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Philips Patient Information Center iX REF recall — Philips North America

Due to software malfunction, patient information system may freeze and become unresponsive.

Official ID Z-3141-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Philips Brilliance CT 64 recall — Philips North America Llc

Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.

Official ID Z-3043-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Philips Ingenuity CT Product Codes recall — Philips North America Llc

Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.

Official ID Z-3042-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Philips IQon Spectral CT Product Codes recall — Philips North America Llc

Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.

Official ID Z-3041-2026 · Official record ↗

FDA Class II · Medical device · September 9, 2026

Philips Brilliance recall — Philips North America Llc

Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.

Official ID Z-3040-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

Cardiac Workstation 7000 recall — Philips North America Llc

Device will intermittently provide inaccurate data related to native heart rate.

Official ID Z-2956-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

Cardiac Workstation 5000 recall — Philips North America Llc

Device will intermittently provide inaccurate data related to native heart rate.

Official ID Z-2955-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Philips Telemetry Monitor 5500 1 recall — Philips North America Llc

Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PI…

Official ID Z-2579-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Philips Avalon Fetal Monitor recall — Philips North America Llc

Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of spe…

Official ID Z-2523-2026 · Official record ↗

FDA Class II · Medical device · July 1, 2026

Philips Avalon Fetal Monitor recall — Philips North America Llc

Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of spe…

Official ID Z-2522-2026 · Official record ↗

FDA Class II · Medical device · June 17, 2026

DigitalDiagnost C90 Flex/Value/Chest/ER recall — Philips North America Llc

System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events.

Official ID Z-2354-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026