BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2885-2020 · Initiated July 8, 2020

    Recall

    Recall Number
    Z-2885-2020
    Event Number
    86077
    Firm
    Canon Medical System, USA, INC.
    FEI Number
    2020563
    Product Code
    OWB
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    July 8, 2020
    Address
    2441 Michelle Dr, Tustin, CA, 92780-7047

    Description

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

    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.

    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.

    Distribution

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

    Quantity

    11 units