System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147
- Company
- Canon Medical System, Usa, Inc.
- Recall Initiated
- July 8, 2020
- Recall Number
- Z-2885-2020
- Quantity
- 11 units
- Firm Location
- Tustin, CA
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.
Distribution
US - CA, CT, ID, LA, MT, NV, OH, SC, WI and WV
Lot / Code Info
The following serial numbers are affected: U4D1992027, U4D19X2029, U4D19Y2030, U4D19Y2031, U4D19Y2033, U4E2012035, U4E2012036, U4E2022037, U4D19Y2032, U4E19Z2034 and U4E2032041.
Root Cause
Software design
Action Taken
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.