FUJIFILM Healthcare Americas Corporation: Device Recall

Recall #Z-1299-2026 · 01/09/2026

Class II: Risk

Recall Details

Recall Number: Z-1299-2026
Classification: Class II
Product Type: Device
Recalling Firm: FUJIFILM Healthcare Americas Corporation
Status: Ongoing
Date Initiated: 01/09/2026
Location: Lexington, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 16 units

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.

Product Description

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

Distribution Pattern

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

Other Recalls by FUJIFILM Healthcare Americas Corporation

Class II: Risk 09/15/2025

It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting.
Class II: Risk 06/11/2025

Devices had an unapproved slabbing software function enabled for use.
Class II: Risk 02/11/2025

The incorrect computed patient age is showing in VX for patients less than 3 months old.

View all recalls by FUJIFILM Healthcare Americas Corporation →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.