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Recall Observatory FDA recall evidence

Device product

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

Z-2885-2020

July 08, 2020

Class II

Product summary

Firm
Canon Medical System, USA, INC.
Event
Event 86077
Status
Ongoing
Classification
Class II
Quantity
11 units
Official record key
device-enforcement:Z-2885-2020

Official wording

Reason: 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.

Code information: The following serial numbers are affected: U4D1992027, U4D19X2029, U4D19Y2030, U4D19Y2031, U4D19Y2033, U4E2012035, U4E2012036, U4E2022037, U4D19Y2032, U4E19Z2034 and U4E2032041.

Distribution pattern: US - CA, CT, ID, LA, MT, NV, OH, SC, WI and WV

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.