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Class 2 Device Recall interventional fluoroscopic xray system |
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Date Initiated by Firm |
July 08, 2020 |
Create Date |
August 25, 2020 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-2885-2020 |
Recall Event ID |
86077 |
510(K)Number |
K181834
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Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
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Product |
System 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. |
Recalling Firm/ Manufacturer |
Canon Medical System, USA, INC. 2441 Michelle Dr Tustin CA 92780-7047
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For Additional Information Contact |
Terry Shultz 714-730-5000
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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.
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FDA Determined Cause 2 |
Software design |
Action |
The 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 Commerce |
11 units |
Distribution |
US - CA, CT, ID, LA, MT, NV, OH, SC, WI and WV |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = OWB and Original Applicant = Canon Medical Systems Corporation
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