HIGH

Philips Medical Systems Recalls Zenition 50 X-Ray Systems Due to Imaging Issues

Philips Medical Systems Nederland B.V. recalled 29 Zenition 50 x-ray systems on September 29, 2025. The devices may suffer from corrosion of the Image Intensifier Television control board, leading to poor image quality. Users must stop using the device immediately and follow the recall instructions.

Quick Facts at a Glance

Recall Date
September 29, 2025
Hazard Level
HIGH
Brand
Philips Medical Systems Nederland B.V.
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
2 states
At-Risk Groups
GENERAL

Hazard Information

Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. or your healthcare provider for instructions. Notification method: Letter

Product Details

The recalled product is the Zenition 50 with Product Number (REF) 718096. It was distributed in the U.S. states of Missouri and Texas, and international locations including Canada and the United Kingdom. The systems were sold before the recall date.

The Hazard

The recall concerns potential loss of imaging functionality and poor image quality. This issue arises from corrosion in the IITV control board, which could affect the diagnostic capabilities of the device.

Reported Incidents

No specific incidents or injuries have been reported. The recall is preventative due to the potential for degraded imaging.

What to Do

Patients and healthcare providers should immediately stop using the Zenition 50 x-ray system. Contact Philips Medical Systems Nederland B.V. or your healthcare provider for further instructions.

Contact Information

For questions, reach Philips Medical Systems Nederland B.V. through their official website or customer service number. Additional recall instructions are available on the FDA website.

Key Facts

  • 29 units recalled
  • Corrosion may cause imaging issues
  • Distributed in multiple countries
  • Class II recall
  • Active status as of September 29, 2025

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeInterventional Fluoroscopic X-Ray System
Sold At
Multiple Retailers

Product Details

Model Numbers
Product Number (REF): 718096
UDI-DI: 00884838091535
All serial numbers
Affected States
MO, TX
Report Date
October 29, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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