Class IIReported 2026-02-11

FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)

Recalled by FUJIFILM Healthcare Americas Corporation

Reason for Recall

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.

Recall Number

Z-1299-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2026-01-09

Reported

2026-02-11

Distribution

US Nationwide distribution in the states of AK, CA, CT, FL, IL, NH, OH, WI.

Code Info

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;

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.