Canon Medical Ultimax-i Imager Processor Recalled for Image Transfer Errors
Canon Medical System is recalling 11 Ultimax-i Imager Processors because images transferred to archival systems may not match the number originally acquired.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The source text describes a data integrity issue (image count mismatch) without reporting any patient injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Canon Medical System, USA, INC. is recalling 11 units of the Ultimax-i (DREX-UI80) system, specifically the HDR-08A Imager Processor. The recall affects specific serial numbers distributed to facilities in California, Connecticut, Idaho, Louisiana, Montana, Nevada, Ohio, South Carolina, Wisconsin, and West Virginia.
The recall was initiated because, during procedures, the number of images displayed in the PACS or image archival system was not the same as the number originally acquired. This discrepancy occurred when images were transferred from the imager to the archival system.
Healthcare facilities should contact Canon Medical System for instructions on how to address the issue. The affected serial numbers are U4D1992027, U4D19X2029, U4D19Y2030, U4D19Y2031, U4D19Y2033, U4E2012035, U4E2012036, U4E2022037, U4D19Y2032, U4E19Z2034, and U4E2032041.
The recalled product
- Product
- System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147
- Manufacturer
- Canon Medical System, USA, INC.
- Affected units
- 11
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- The following serial numbers are affected: U4D1992027
- U4D19X2029
- U4D19Y2030
- U4D19Y2031
- U4D19Y2033
- U4E2012035
- U4E2012036
- U4E2022037
- U4D19Y2032
- U4E19Z2034 and U4E2032041.
Distribution
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