Canon Medical System, USA, INC. System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147
Brand
Canon Medical System, USA, INC.
Lot Codes / Batch Numbers
The following serial numbers are affected: U4D1992027, U4D19X2029, U4D19Y2030, U4D19Y2031, U4D19Y2033, U4E2012035, U4E2012036, U4E2022037, U4D19Y2032, U4E19Z2034 and U4E2032041.
Products Sold
The following serial numbers are affected: U4D1992027, U4D19X2029, U4D19Y2030, U4D19Y2031, U4D19Y2033, U4E2012035, U4E2012036, U4E2022037, U4D19Y2032, U4E19Z2034 and U4E2032041.
Canon Medical System, USA, INC. is recalling System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)049876 due to During a procedure, when images were acquired, and these images were transferred to PACS /image archival system, the number of images displayed were n. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CT, ID, LA, MT, NV, OH, SC, WV, WI
Page updated: Jan 10, 2026