United StatesFUJIFILM’s FDR Visionary Suite X‑ray system, model CH‑200 (versions 566-16130-23, 566-16130-31, 566-16130-33 and the specific serial numbers and UDI‑DIs listed in the notice) is affected. The electromagnetic contactor contacts inside the high‑voltage generator cabinet can weld, allowing current to remain supplied after power is cut, which may cause overheating, damage to surrounding parts, and smoke.
What's being recalled
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
Recalling firm: FUJIFILM Healthcare Americas Corporation, Lexington, MA, United States.
How to identify it
Model Number: CH-200; (1) Version: 566-16130-23; UDI-DI: 04540217052226; Serial numbers: MP95A9F6A001, MP95A9F6B001, MP95A9F74001, MP95A9F74002, MP95A9F76001, MP95A9F78001; (2) Version: 566-16130-31; UDI-DI: 04540217057436; Serial numbers: MP95AA783001; (3) Version: 566-16130-33; UDI-DI: 04540217057450; Serial numbers: MP95AA983001, MP95AA983002, MP95AA983003, MP95AA985001, MP95AA985003, MP95AA985002, MP95AA988001, MP95AA988002;
The hazard
It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it cannot be denied that the circuit in question overheats and damages the surrounding parts. It may also cause smoke.
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
US Nationwide distribution in the states of AK, CA, CT, FL, IL, NH, OH, WI.
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)