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

FDA device recall Z-1299-2026 · posted 2026-02-05 · Open, Classified

Recall details

Recalling firm

FUJIFILM Healthcare Americas Corporation

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.

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

KPR

Quantity affected

16 units

Distribution

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

Date initiated

2026-01-09

Date posted

2026-02-05

Location

Lexington, MA

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