FDA Medical Device Recalls (openFDA)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
- Recall number
- Z-0241-2026
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product
- Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
- Status
- Open, Classified
- Initiated
- 2025-09-29
- Posted
- 2025-10-23
- Terminated
- not on file
- 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 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.
- 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.
- Lot, serial or model codes
- Product Number (REF): 718096; UDI-DI: 00884838091535; All serial numbers;
- 510(k) numbers
- ["K183101"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 3002807880
- Firm city
- Best
- Firm state
- not on file
- Firm country
- Netherlands
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28