FDA recall Z-1299-2026

FUJIFILM Healthcare Americas Corporation · Class II · device

Product

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2026-01-09
Report date
2026-02-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lexington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1299-2026