Interventional fluoroscopy systems recalled over control board corrosion affecting imaging
Philips is recalling 29 Zenition 50 interventional fluoroscopic X-ray systems because corrosion of the image intensifier television control board may cause loss of imaging or poor image quality.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: degraded or lost imaging on an interventional system used during procedures is a clinical risk, and no injuries are reported.
Plain-English summary
The Zenition 50 interventional fluoroscopic X-ray system, product number 718096, is being 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.
The recall covers 29 units carrying UDI-DI 00884838091535 across all serial numbers, distributed in Missouri and Texas and to Belgium, Canada, Fiji, Germany, India, Malaysia, Mexico, Morocco and South Africa among other countries. The FDA has classified the action as Class II.
The enforcement record describes the imaging failure and reports no injuries. Sites should follow Philips' instructions.
The recalled product
- Product
- Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Affected units
- 29
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Product Number (REF): 718096
- UDI-DI: 00884838091535
- All serial numbers
Distribution
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