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U.S. Department of Health and Human Services

Class 2 Device Recall FDR Visionary Suite

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 Class 2 Device Recall FDR Visionary Suitesee related information
Date Initiated by FirmJanuary 09, 2026
Date PostedFebruary 05, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1299-2026
Recall Event ID 98124
510(K)NumberK152294 
Product Classification System, x-ray, stationary - Product Code KPR
ProductFDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
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;
FEI Number 1000513161
Recalling Firm/
Manufacturer		 FUJIFILM Healthcare Americas Corporation
81 Hartwell Ave Ste 300
Lexington MA 02421-3160
For Additional Information ContactKotei Aoki
765-246-2931
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionOn 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.
Quantity in Commerce16 units
DistributionUS Nationwide distribution in the states of AK, CA, CT, FL, IL, NH, OH, WI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KPR
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