BEUDAMED
    FDA Recall Terminated

    ECAT PET Scanners (mobile systems), distributed by Siemens Medical Solutions ECAT PET Scanners (mobile systems), and Reveal XL (mobile systems), distributed by CTI Molecular Imagining, Inc. Sceptre and Sceptre XL (mobile systems) distributed by Hitachi Medical Systems America

    Recall: Z-0819-05 · Initiated April 5, 2005

    Recall

    Recall Number
    Z-0819-05
    Event Number
    31770
    Firm
    CTI PET Systems Inc
    FEI Number
    1034973
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 5, 2005
    Posted
    May 11, 2005
    Terminated
    September 11, 2009
    Address
    810 Innovation Drive, Knoxville, TN, 37932-2571

    Description

    ECAT PET Scanners (mobile systems), distributed by Siemens Medical Solutions ECAT PET Scanners (mobile systems), and Reveal XL (mobile systems), distributed by CTI Molecular Imagining, Inc. Sceptre and Sceptre XL (mobile systems) distributed by Hitachi Medical Systems America

    Reason

    Failure to properly secure the Mobile Bed Supports during transit could cause the support screws on the Patient Handling System to become loose and possibly break due to increased vibration during transit.

    Action

    Written notification via certified US Mail was sent out beginning 04/05/2005 to distributors and end users (with whom CTI had a service contract) to advise them of the problem.

    Distribution

    Nationwide, Canada, the Netherlands, Ireland & Denmark

    Quantity

    80 units