Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
Recall
- Recall Number
- Z-0241-2026
- Event Number
- 97682
- Firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands
- FEI Number
- 3002807880
- Product Code
- OWB
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- September 29, 2025
- Posted
- October 23, 2025
Description
Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
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.
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 representative. 5. If you experience the issue described in this letter, please report it to your local Philips representative. Actions by Philips: Starting in October 2025, Philips will replace the 11W control board of the affected Zenition 50 systems. Your local Philips representative will contact you to schedule a visit to perform this activity in your system.
Distribution US states of MO and TX; Belgium, Canada, Fiji, Germany, India, Malaysia, Mexico, Morocco, South Africa, South Korea, Thailand, United Kingdom, and Uzbekistan.
29 units