Canon Medical recalls Ultimax-i DREX-UI80 units with HDR-08A Imager Processor model where image counts differ from original during PACS transfer. Affected units have specific serial numbers listed in the recall notice.
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.
Canon Medical is recalling certain Ultimax-i imaging systems that display a different number of images than originally acquired when transferred to PACS systems. This mismatch could lead to incorrect medical records and potential misdiagnosis if not addressed.
When images are transferred from the system to PACS (medical image storage), the number of images displayed may not match what was originally captured. This discrepancy could result in missing or extra images in medical records, potentially affecting diagnosis and treatment decisions.
Healthcare facilities using Canon Ultimax-i imaging systems with the specific HDR-08A Imager Processor model are affected. Medical staff and patients using these systems may be at risk of incorrect imaging records.
Check for the specific serial numbers listed: U4D1992027, U4D19X2029, U4D19Y2030, U4D19Y2031, U4D19Y2033, U4E2012035, U4E2012036, U4E2022037, U4D19Y2032, U4E19Z2034, and U4E2032041. The affected units have the System Model: Ultimax-i, DREX-UI80 and Unit Model: HDR-08A Imager Processor.
Verify if your unit has one of the listed serial numbers: U4D1992027, U4D19X2029, U4D19Y2030, U4D19Y2031, U4D19Y2033, U4E2012035, U4E2012036, U4E2022037, U4D19Y2032, U4E19Z2034, or U4E2032041.
The recall is happening because the system displays a different number of images than originally acquired when transferred to PACS systems, which could lead to incorrect medical records.
Check if your unit has one of the specific serial numbers listed in the recall notice: U4D1992027, U4D19X2029, U4D19Y2030, U4D19Y2031, U4D19Y2033, U4E2012035, U4E2012036, U4E2022037, U4D19Y2032, U4E19Z2034, or U4E2032041.
The recall does not specify a remedy, so affected units should be checked by Canon Medical for potential correction or replacement.
We’ve drafted a message you can send Canon Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2885-2020 — Canon Medical Canon Medical Hello, I own a Canon Medical that is covered by recall Z-2885-2020 from Canon Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
