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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands Recalls

All product recalls associated with PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands.

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Recall Summary

Total Recalls

147

Past Year

Class I (Serious)

Most Recent

Oct 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 41–60 of 147 recalls

Allura Xper X-Ray System (Philips) – component missing (2025)

Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series.

Moderate

FDAAug 1, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Pinnacle 3 TumorLOC (Philips) – Calculation Error (2025)

Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,

Moderate

FDAJul 17, 2025Nationwide• Philips Medical Systems (Cleveland) Inc

Allura R8.2.x Systems (Philips) – Imaging Functionality Loss (2025)

Potential for temporary loss of imaging (X-ray) functionality due to software issue.

Moderate

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Page 3 of 8Next

FDA

Jun 30, 2025

Nationwide

• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Azurion 7 M20 X-Ray (Philips Medical) – Gearbox Bolt Loosening (2025)

Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.

Moderate

FDAJun 4, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Azurion R1.x and R2.x Systems (Philips) – Communication Software Issue (2025)

Laceration Risk

A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the two situations identified could result in a delay of therapy. The potential delay may result in serious adverse health outcomes, including the possibility of death, especially when the system is used with patients undergoing complex and/or urgent interventions for potentially life-threatening conditions (e.g., acute ischemic stroke, ST-segment elevation myocardial ischemia, life-threatening bleedings).

Very High

FDAMay 28, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

SmartPath to dStream (Philips) – QBC seal failure (2025)

Laceration Risk

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

Moderate

FDAMar 24, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Spectral CT on Rails (Philips) – Software Scanning Problems (2025)

Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.

Moderate

FDAFeb 28, 2025MN• Philips Medical Systems Nederland B.V. Veenpluis

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands Recalls

Recall Summary

Allura Xper X-Ray System (Philips) – component missing (2025)

Pinnacle 3 TumorLOC (Philips) – Calculation Error (2025)

Allura R8.2.x Systems (Philips) – Imaging Functionality Loss (2025)

Azurion 7 M20 X-Ray (Philips Medical) – Gearbox Bolt Loosening (2025)

Azurion R1.x and R2.x Systems (Philips) – Communication Software Issue (2025)

SmartPath to dStream (Philips) – QBC seal failure (2025)

Intera 1.5T R11 (Philips) – Coil Seal Adhesive Failure (2025)

Intera 1.5T Power/Pulsar (Philips) – Coil Seal Adhesive Failure (2025)

Intera 1.0T Power/Pulsar (Philips) – Coil Seal Adhesive Failure (2025)

Intera 1.5T Omni/Stellar (Philips) – Coil Seal Adhesive Failure (2025)

Enterprise 1.5T (Philips) – Coil Seal Adhesive Failure (2025)

SmartPath to dStream (Philips) – Coil Seal Adhesive Failure (2025)

Intera CV (Philips) – Coil Seal Adhesive Failure (2025)

Intera 3.0T Quasar Dual (Philips) – Coil Seal Adhesive Failure (2025)

Intera 1.5T Explorer/Nova Dual (Philips) – Coil Seal Adhesive Failure (2025)

Intera 1.5T Master/Nova (Philips) – Coil Seal Adhesive Failure (2025)

Intera 1.0T Omni/Stellar (Philips) – Coil Seal Adhesive Failure (2025)

Intera 0.5T Standard (Philips) – Coil Seal Adhesive Failure (2025)

Intera 1.5T (Philips) – Coil Seal Adhesive Failure (2025)

Spectral CT on Rails (Philips) – Software Scanning Problems (2025)