FDA-Device2020-09-02Class II
System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147
Canon Medical System, USA, INC.
Hazard
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.
Sold states
US - CA, CT, ID, LA, MT, NV, OH, SC, WI and WV
Affected count
11 units
Manufactured in
2441 Michelle Dr, N/A, Tustin, CA, United States
Products
System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2885-2020Don't want to check this manually?
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