BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-2885-2020 · Reported September 2, 2020

    Enforcement

    Recall Number
    Z-2885-2020
    Event ID
    86077
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Canon Medical System, USA, INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    FAX
    Report Date
    September 2, 2020
    Initiation Date
    July 8, 2020
    Classification Date
    August 25, 2020
    Address
    2441 Michelle Dr, N/A, Tustin, CA, 92780-7047, United States

    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.

    Code Info

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

    Distribution

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

    Quantity

    11 units