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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 FirmApril 11, 2024
Date PostedMay 24, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1898-2024
Recall Event ID 94443
510(K)NumberK152294 
Product Classification System, x-ray, stationary - Product Code KPR
ProductFDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. Model/Catalog Number: 566-16130-23 566-16130-33
Code Information UDI-DI: 04540217052226 04540217057450 S/N: MP95A9F6A001, MP95A9F74002, MP95A9F74001, MP95AA983002, MP95AA985001, MP95AA985003, MP95AA985002, MP95AA988001, MP95AA993001, MP95AA996002, MP95AA996001, MP95AA997001, MP95A9F6B001, MP95A9F76001, MP95AA983001, MP95AA988002, MP95AA98A001, MP95AA993002
FEI Number 1000513161
Recalling Firm/
Manufacturer		 FUJIFILM Healthcare Americas Corporation
81 Hartwell Ave Ste 300
Lexington MA 02421-3160
For Additional Information ContactSAME
617-861-5300
Manufacturer Reason
for Recall		Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury
FDA Determined
Cause 2		Component design/selection
ActionFUJIFILM Healthcare Americas Corporation (FUJIFILM) issued Urgent -FIrst Notice letter via email on 4/11/24. Letter states reason for recall, health risk and action to take: 1)Please complete and return the form attached on page 3 of this communication. Providingthe response with the information requested is essential for ensuring appropriate action istaken 2)Please contact Customer Service at 1-888-FUJIMED (1-888-385-4633) to open a serviceticket. 3)Until your upgrade is scheduled and completed, you can continue to safely use FDRVisionary Suite, however, inspect the bolts prior to use. Please contact our field action coordinator, Chaitrali Kulkarni, via email at hcusregulatoryaffairs@fujifilm.com, if you have any further questions regarding this field action.
Quantity in Commerce18 units
DistributionUS Nationwide distribution in the states of AK, CA, FL, IL, NE, NH, OH, TN, 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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