BEUDAMED
    FDA Recall Terminated

    Siemens Models: BIOGRAPH, BIOGRAPH LSO and CTI Models: REVEAL HD, REVEAL RT

    Recall: Z-0106-04 · Initiated October 2, 2003

    Recall

    Recall Number
    Z-0106-04
    Event Number
    27358
    Firm
    Cti Pet Systems Inc
    FEI Number
    1034973
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 2, 2003
    Posted
    November 13, 2003
    Terminated
    February 7, 2006
    Address
    810 Innovation Drive, Knoxville, TN, 37932-2571

    Description

    Siemens Models: BIOGRAPH, BIOGRAPH LSO and CTI Models: REVEAL HD, REVEAL RT

    Reason

    CPS has found that in some instances, when the CT E-Stop is activated, a malfunction may occur where the PHS controller may not shut down and stop bed motion.

    Action

    Written notification was sent out beginning 10/02/2003 to distributors and end users to advise them of the problem.

    Distribution

    Nationwide International: Japan, Germany, Brazil, Spain, China, Russia, Austrailia, Hong Kong, Singapore, Poland France, Korea, Greece, UK and Austria

    Quantity

    73