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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product type
- Interventional fluoroscopic x-ray system
- Model numbers
- Product Number (REF): 718096, UDI-DI: 00884838091535, All serial numbers
- Sold at
- Unknown
- Where affected
- MO, TX
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 29, 2025
Reported by FDA DEVICE
October 29, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Check Product Number (REF) 718096
- 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
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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
- 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)
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Safety Guide
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