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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 FirmSeptember 15, 2025
Date PostedOctober 07, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0044-2026
Recall Event ID 97581
510(K)NumberK152294 
Product Classification System, x-ray, stationary - Product Code KPR
ProductFDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
Code Information Model/Version Number: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33; UDI-DI: (1) 04540217052226, (2) 04540217057436, (3) 04540217057450; Serial Numbers: (1) MP95A8F5A001, MP95A9F6A001, MP95A9F6B001, MP95A9F74001, MP95A9F74002, MP95A9F76001, MP95A9F78001, (2) MP95AA783001, (3) MP95AA983001, MP95AA983002, MP95AA983003, MP95AA985001, MP95AA985003, MP95AA985002, MP95AA988001, MP95AA988002;
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 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.
FDA Determined
Cause 2		Device Design
ActionOn September, 15, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: Perform the daily inspection described in the operation manual to check for wobbles or shakes, misalignment of the light irradiation position, etc. If any abnormality is found, discontinue use and contact Technical Assistance Center (TAC). When rotating the X-ray tube unit, do not hit the stopper at the end. Do not rotate the X-ray tube over or near the patient. Please post this notice on or near the device. Complete and return the response form provided. Fujifilm Service Engineers will install countermeasure parts that will prevent the X-ray tube support from coming off even if the shaft is damaged. Please contact Technical Assistance Center (TAC) at 1-888-385-4633 or 1-888-FUJIMED for any functional/correction questions as well as to schedule your correction.
Quantity in Commerce16 units
DistributionDomestic: AK, CA, FL, IL, MA, 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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