United StatesThe affected product is the Philips Zenition 50 interventional fluoroscopic x-ray system (Product Number REF 718096, UDI‑DI 00884838091535; all serial numbers; 29 units distributed in MO and TX in the U.S. and in Belgium, Canada, Fiji, Germany, India, Malaysia, Mexico, Morocco, South Africa, South Korea, Thailand, the United Kingdom, and Uzbekistan). The systems were recalled because potential corrosion of the Image Intensifier Television (IITV) control board may lead to loss of imaging functionality and/or poor image quality.
What's being recalled
Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
Recalling firm: Philips Medical Systems Nederland B.V., Best, Netherlands.
How to identify it
Product Number (REF): 718096; UDI-DI: 00884838091535; All serial numbers;
The hazard
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 to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Distribution US states of MO and TX; Belgium, Canada, Fiji, Germany, India, Malaysia, Mexico, Morocco, South Africa, South Korea, Thailand, United Kingdom, and Uzbekistan.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada