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U.S. Department of Health and Human Services

Class 2 Device Recall interventional fluoroscopic xray system

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 Class 2 Device Recall interventional fluoroscopic xray systemsee related information
Date Initiated by FirmJuly 08, 2020
Create DateAugust 25, 2020
Recall Status1 Open3, Classified
Recall NumberZ-2885-2020
Recall Event ID 86077
510(K)NumberK181834 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductSystem Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147
Code Information The following serial numbers are affected: U4D1992027, U4D19X2029, U4D19Y2030, U4D19Y2031, U4D19Y2033, U4E2012035, U4E2012036, U4E2022037, U4D19Y2032, U4E19Z2034 and U4E2032041. 
FEI Number 2020563
Recalling Firm/
Manufacturer		 Canon Medical System, USA, INC.
2441 Michelle Dr
Tustin CA 92780-7047
For Additional Information ContactTerry Shultz
714-730-5000
Manufacturer Reason
for Recall		During a procedure, when images were acquired, and these images were transferred to PACS /image archival system, the number of images displayed were not the same as originally acquired.
FDA Determined
Cause 2		Software design
ActionThe recall letters were sent via facsimile between 07/08-10/2020. The letter contains a return reply form that is to be completed by the customer and faxed to CMSU for retention. After approximately one month contact will be made with each non-responding location and a copy of the letter will be faxed to that location and the fax receipt will serve as proof of notification.
Quantity in Commerce11 units
DistributionUS - CA, CT, ID, LA, MT, NV, OH, SC, WI and WV
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 = OWB
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