HIGH

Philips Medical Systems Nederland 718096 Zenition 50 Interventional X-Ray System Recalled in 2025

Philips Medical Systems Nederland B.V. recalled 29 Zenition 50 interventional fluoroscopic x-ray systems distributed in 14 countries. The defect is corrosion of the IITV control board that may cause loss of imaging functionality or poor image quality. Healthcare providers and patients should stop using the device and follow manufacturer instructions for recall remediation.

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
Unknown
Geographic Scope
2 states
At-Risk Groups
GENERAL, PREGNANT

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

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About This Product

The Zenition 50 is an interventional fluoroscopic x-ray system used in complex diagnostic and therapeutic procedures.

Why This Is Dangerous

Corrosion on the IITV control board can degrade image quality, potentially affecting procedural accuracy and patient safety.

Industry Context

This recall is not identified as part of a broader industry-wide pattern in the provided data.

Real-World Impact

The recall directly affects imaging performance critical to interventional radiology procedures, potentially impacting treatment timelines if remediation is delayed.

Practical Guidance

How to identify if yours is affected

  1. Check Product Number (REF) 718096
  2. Check UDI-DI 00884838091535
  3. Review distribution list for MO and TX and international regions

Where to find product info

Manufacturer recall notice and FDA enforcement page linked in the source

What timeline to expect

Remediation timelines are determined by Philips; hospitals may implement temporary imaging protocols as needed

If the manufacturer is unresponsive

  • Escalate to hospital risk management
  • Request remediation timeline in writing
  • Document all communications and device identifiers

How to prevent similar issues

  • Verify device serial numbers during purchasing
  • Ensure device tracking systems capture REF and UDI-DI
  • Maintain vendor outreach for recall notifications

Documentation advice

Keep a record of recall notices, communications, and remediation actions with dates

Product Details

Brand: Philips Medical Systems Nederland B.V. Product: Zenition 50 Interventional fluoroscopic x-ray system. Product Number (REF): 718096. UDI-DI: 00884838091535. Quantity: 29 units. Distribution: US states of Missouri and Texas; international distribution to Belgium, Canada, Fiji, Germany, India, Malaysia, Mexico, Morocco, South Africa, South Korea, Thailand, United Kingdom, Uzbekistan. Status: Active recall as of 2025-10-29.

Reported Incidents

No specific incidents or injuries are documented in the provided recall notice.

Key Facts

  • 29 units recalled
  • Product REF 718096
  • UDI-DI 00884838091535
  • Distributed in MO, TX and multiple countries
  • Hazard: IITV board corrosion causing imaging loss or poor image quality
  • Recall date: 2025-09-29 (recall) / 2025-10-29 (report)

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANT
Injury Types
ELECTRICALPOISONINGBURN

Product Details

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

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