FUJIFILM Healthcare Americas Corporation recalls FDR Visionary Suite

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.

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

On January 9, 2026 URGENT: MEDICAL DEVICE RECALL letters were emailed to customers. Actions to be taken: Please pay attention to the following points until the work is completed. " For safety reasons, please turn off the breaker of the distribution board to which the power cord of the unit is connected after turning off the power of the unit according to the operation manual. " Do not forget to turn off the breaker of the distribution board until the replacement of the contactor is completed. 1) Please post this notification on or near the device 2) Please complete and return the Field Action Verification Form attached to this communication. Responding with the information requested is essential for ensuring appropriate action is taken. 3) Please contact Technical Assistance Center (TAC) at 1-888-FUJIMED (1-888-385-4633) to open a service ticket. 4) Please report any known adverse events to FDA via MedWatch.

• FDA enforcement recordOfficial FDA database entry for Z-1299-2026
• FDA 510(k) clearance · K152294The device's official FDA premarket clearance record
• FDA device classification · KPROfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1680The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find FUJIFILM Healthcare Americas CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.