FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
FDA Recall #Z-1299-2026 — Class II — January 9, 2026
Product Description
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
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.
Recalling Firm
FUJIFILM Healthcare Americas Corporation — Lexington, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
16 units
Distribution
US Nationwide distribution in the states of AK, CA, CT, FL, IL, NH, OH, WI.
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;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated