FUJIFILM Healthcare Americas Corporation recalls FDR Visionary Suite

Recalling company

FUJIFILM Healthcare Americas Corporation

Product

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

Reason

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Jan 9, 2026

Reported

Feb 11, 2026

Distribution

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

Status

Ongoing

Quantity

16 units

Lot / codes

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;

Company location

Lexington, MA

Recall type

Voluntary: Firm initiated

Recall number

Z-1299-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1299-2026 in the FDA Enforcement Report. Also see FDA recall press releases.