CLASS II ONGOING Device recall · Reported 29 Oct 2025 · FDA Enforcement Report
Zenition 50; Product Number recalled by Philips Medical Systems
Philips Medical Systems Nederl is recalling Zenition 50; Product Number (, distributed in Missouri, Texas. The recall was initiated on 29 Sep 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0241-2026
- FDA event ID
- 97682
- Recalling firm
- Philips Medical Systems Nederl, Best
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Sep 2025
- FDA classified
- 23 Oct 2025
- Reported
- 29 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 29 Sep 2025 | Recall initiated by company | |
| 23 Oct 2025 | Classified by FDA | +24 days |
| 29 Oct 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
Where it was distributed
Distribution US states of MO and TX; Belgium, Canada, Fiji, Germany, India, Malaysia, Mexico, Morocco, South Africa, South Korea, Thailand, United Kingdom, and Uzbekistan.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Product Number (REF): 718096; UDI-DI: 00884838091535; All serial numbers;
Where was it sold?
Distribution US states of MO and TX; Belgium, Canada, Fiji, Germany, India, Malaysia, Mexico, Morocco, South Africa, South Korea, Thailand, United Kingdom, and Uzbekistan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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