BEUDAMED
    FDA Recall Terminated

    Integrated Orbiter Single Detector General Purpose Gamma Camera System; Siemens Medical Systems, Inc., Nuclear Medicine Group, 2501 North Barrington Road, Hoffman Estates, IL 60195-5203

    Recall: Z-0617-03 · Initiated February 10, 2003

    Recall

    Recall Number
    Z-0617-03
    Event Number
    25544
    Firm
    Siemens Medical Solutions USA, Inc.
    FEI Number
    1000514697
    Product Code
    IYX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 10, 2003
    Posted
    March 6, 2003
    Terminated
    April 30, 2004
    Address
    2501 N. Barrington Road, Hoffman Estates, IL, 60195-5203

    Description

    Integrated Orbiter Single Detector General Purpose Gamma Camera System; Siemens Medical Systems, Inc., Nuclear Medicine Group, 2501 North Barrington Road, Hoffman Estates, IL 60195-5203

    Reason

    Unintended yoke rotational motion.

    Action

    Siemens sent Customer Advisory letters dated 2/10/03 to all Integrated Orbiter customers. The accounts were informed of the problem with unexpected camera movement in the opposite direction at the beginning of a SPECT study, and were advised to use the emergency stop at any indication of improper camera movement. The customers were advised that they would be contacted by their Siemens Customer Service Representative to schedule a firmware upgrade that will prevent the occurrence of unintended camera rotation. The upgrade will be done free of charge.

    Distribution

    Nationwide, United Arab Emirates, Argentina, Austria, Azerbaizan,Bangladesh, Belgium, Brazil, Canada, China, Colombia, Cyprus, France, Germany, Great Britain, Greece, Hong Kong, India, Ireland, Italy, Jordan, Japan, Korea, Norway, Pakistan, Romania, Switzerland, Tunisia, Venezuela and the Netherlands.

    Quantity

    256 units