medical Class II Updated 2020-09-02

Canon Medical System, USA, INC. recalls System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model:

Recalled Product

System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147

Hazard / Issue

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.

Issued by

FDA

Affected States: CA, CT, ID, LA, MT, NV, OH, SC, WI, WV
Lot/Code Info: The following serial numbers are affected: U4D1992027, U4D19X2029, U4D19Y2030, U4D19Y2031, U4D19Y2033, U4E2012035, U4E2012036, U4E2022037, U4D19Y2032, U4E19Z2034 and U4E2032041.
View official government recall

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