FDA Medical devices recall ·
Zenition 50 recall
- Recall number
- Z-0241-2026
- Date
- (initiated September 29, 2025)
- Company / brand
- Philips Medical Systems Nederland B.V.
Veenpluis 4-6, Best, Netherlands - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 29 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Product Number (REF): 718096; UDI-DI: 00884838091535; All serial numbers;
Distribution
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 does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0241-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.