BEUDAMED
    FDA Recall Terminated

    Rational Imaging TM Software, model Ultra 10 PACS System Version 7.1.Xx

    Recall: Z-0905-03 · Initiated March 11, 2003

    Recall

    Recall Number
    Z-0905-03
    Event Number
    26260
    Firm
    Canon USA Inc
    FEI Number
    3017088497
    Product Code
    LMB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 11, 2003
    Posted
    June 5, 2003
    Terminated
    May 12, 2004
    Address
    15955 Alton Parkway, Irvine, CA, 92618

    Description

    Rational Imaging TM Software, model Ultra 10 PACS System Version 7.1.Xx

    Reason

    Imaging archive system software mismatches images and patient names.

    Action

    Recall letters were sent March 11, 2003. Another mailing was sent March 26, 2003 with stickers and preventative practice suggestions. A software fix will be available to customers in the near future.

    Distribution

    States of IA, CA , AR, WA, OR

    Quantity

    34