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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

1000

Class I (Serious)

Most Recent

Jan 2026

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 861–880 of 21319 recalls

Evolution Upgrade 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.

Low

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.

Low

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.

Low

FDA

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May 13, 2025

Nationwide

• Philips North America Llc

Ingenia 3.0T CX (Philips) – Image Alignment Error (2025)

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

Low

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.

Low

FDAMay 13, 2025Nationwide• Philips North America Llc

Esomeprazole Magnesium Suspension 20mg (Zydus) – Impurity Specification (2025)

Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.

Class IIModerate

FDAMay 13, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Esomeprazole Magnesium Suspension 40mg (Zydus) – Impurity Specification (2025)

Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.

Class IIModerate

FDAMay 13, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

MR 7700 Upgrade (Philips) – Image Alignment Error (2025)

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

Low

FDAMay 13, 2025Nationwide• Philips North America Llc

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

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

Low

FDAMay 13, 2025Nationwide• Philips North America Llc

BiPAP A40 Ventilator (Philips) – Usage Limitation (2025)

This device does not indicate for use in patients with respiratory failure.

High

FDAMay 9, 2025Nationwide• Philips Respironics, Inc.

BiPAP V30 Ventilator (Philips) – Usage Limitation (2025)

This device does not indicate for use in patients with respiratory failure.

High

FDAMay 9, 2025Nationwide• Philips Respironics, Inc.

Celecoxib Capsules (Alembic) – Foreign Tablet Contamination (2025)

Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule

Class IIModerate

FDAMay 9, 2025Nationwide• Alembic Pharmaceuticals Limited

VITROS 5600 System (Ortho-Clinical) – Test Result Error (2025)

A software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.

Moderate

FDAMay 9, 2025Nationwide• Ortho-Clinical Diagnostics, Inc.

BiPAP A30 Ventilators (Philips) – Usage Limitation (2025)

This device does not indicate for use in patients with respiratory failure.

High

FDAMay 9, 2025Nationwide• Philips Respironics, Inc.

Zen-O Lite Oxygen Concentrator (Ohio Medical) – Calibration Error (2025)

Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will gradually decrease to the point where the device alarms to indicate low oxygen purity will be incorrect.

Moderate

FDAMay 8, 2025Nationwide• Ohio Medical Corporation

Z-800W Infusion System (Zyno Medical) – Unreleased Software (2025)

Unreleased software versions were installed on distributed devices without verification or validation.

Moderate

FDAMay 7, 2025Nationwide• Zyno Medical LLC

SmartRelease ESTR (MicroAire) – Unintended Blade Cut (2025)

Laceration Risk

Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.

High

FDAMay 7, 2025Nationwide• MicroAire Surgical Instruments, LLC

Z-800 Infusion System (Zyno Medical) – Unreleased Software (2025)

Unreleased software versions were installed on distributed devices without verification or validation.

Moderate

FDAMay 7, 2025Nationwide• Zyno Medical LLC

Z-800WF Infusion System (Zyno Medical) – Unreleased Software (2025)

Unreleased software versions were installed on distributed devices without verification or validation.

Moderate

FDAMay 7, 2025Nationwide• Zyno Medical LLC

Z-800F Infusion System (Zyno Medical) – Unreleased Software (2025)

Unreleased software versions were installed on distributed devices without verification or validation.

Moderate

FDAMay 7, 2025Nationwide• Zyno Medical LLC