Reported Sep 2, 2020 · Ongoing
System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147
Canon Medical System, USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Canon Medical System, USA, INC. · 2441 Michelle Dr · Tustin, CA · 92780-7047
Is this the product you have?
- System ModelUltimax-i, DREX-UI80 (DREX-UI80)
- Unit Model
HDR-08A Imager ProcessorUDI (01)04987670100147
- Lot codes and dates
- The
- following serial numbers are affected
U4D1992027U4D19X2029U4D19Y2030U4D19Y2031U4D19Y2033U4E2012035U4E2012036U4E2022037U4D19Y2032U4E19Z2034 and U4E2032041
- Amount recalled
- 11 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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