FUJIFILM Healthcare Americas Corporation: Medical Device Recall in 2026 - (Recall #: Z-1299-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 9, 2026

Date Posted: February 11, 2026

Recall Number: Z-1299-2026

Event ID: 98124

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.

Status: Ongoing

Product Quantity: 16 units

Code Information:

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;

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated