System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147
FDA Recall Z-2885-2020 · Posted None
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Recalling FirmCanon Medical System, USA, INC.
Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2020-07-08
Product Quantity11 units
Reason for Recall
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.
Firm Action
The recall letters were sent via facsimile between 07/08-10/2020. The letter contains a return reply form that is to be completed by the customer and faxed to CMSU for retention. After approximately one month contact will be made with each non-responding location and a copy of the letter will be faxed to that location and the fax receipt will serve as proof of notification.
Root Cause
Software design
Distribution Pattern
US - CA, CT, ID, LA, MT, NV, OH, SC, WI and WV
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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