FDR Visionary Suite X-ray Generator
FDR Visionary Suite X-ray generators are being recalled due to a risk of overheating and smoke caused by faulty electromagnetic contactors.
Stop using the affected X-ray high-voltage generator and contact FUJIFILM Healthcare Americas Corporation for inspection and repair services.
Why it was recalled
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.
How to identify it
UPC 04540217052226 04540217057436 04540217057450
FDR Visionary Suite;
Where it was sold
Distributed nationwide.
Official source
Editorial summary by Recall Canary · last updated 2026-05-22 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification