Canon Ultimax-i Imager Processor Recall: Image Count Mismatch Risk
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.
Lower-risk 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.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/64743-canon-ultimax-i-imager-processor-recall-image-count-mismatch-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/64743-canon-ultimax-i-imager-processor-recall-image-count-mismatch-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2885-2020
Cite this page
“Canon Ultimax-i Imager Processor Recall: Image Count Mismatch Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64743-canon-ultimax-i-imager-processor-recall-image-count-mismatch-risk. Based on FDA recall #Z-2885-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2885-2020%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Canon Medical- Product
System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147- Category
Medical device
What to do — step by step
Check Serial Numbers
Verify if your unit has one of the listed serial numbers: U4D1992027, U4D19X2029, U4D19Y2030, U4D19Y2031, U4D19Y2033, U4E2012035, U4E2012036, U4E2022037, U4D19Y2032, U4E19Z2034, or U4E2032041.
Where it went and when
Where it was distributed
Distributed in 10 states.
FDA distribution: “US - CA, CT, ID, LA, MT, NV, OH, SC, WI and WV” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Connecticut, Idaho, Louisiana, Montana, Nevada, Ohio, South Carolina, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 56 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-2885-2020 (July 8, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2885-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.