Recall Z-0241-2026 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
| Date | Oct 23, 2025 (initiated Sep 29, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | On September 29, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: 1. Circulate this notice to all users and follow the instructions in the letter. 2. Affected systems may continue to be used in accordance with their intended use and Instructions for Use (IFU). 3. Ensure the letter is in a place likely to be seen/viewed. 4. In case the affected system has been transferred to another organization, please send a copy of this Urgent Medical Device Correction letter to that organization and inform Philips about this transfer through your local Philips repre |
| Quantity | 29 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183101 | Zenition 50 Philips Medical Systems Nederland B.V., Dec 31, 2018 |