BEUDAMED
    FDA Recall Terminated

    BrightView Gamma Camera Radius Drive Assembly, manufactured by Philips Medical Systems (Cleveland) Inc., Cleveland, OH, 3/8" tilt, model number 4535604 34811, 3/4"tilt, model number 4535674 34801, and 3/8" fixed, model number 4535604 34781, all catalog number 882480 Medical device-- intended to produce images depicting anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.

    Recall: Z-1892-2009 · Initiated July 2, 2009

    Recall

    Recall Number
    Z-1892-2009
    Event Number
    52704
    Firm
    Phillips Nuclear Medicine
    FEI Number
    1525965
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 2, 2009
    Posted
    September 16, 2009
    Terminated
    April 12, 2010
    Address
    540 Alder Dr, Bldg 4, Milpitas, CA, 95035-7443

    Description

    BrightView Gamma Camera Radius Drive Assembly, manufactured by Philips Medical Systems (Cleveland) Inc., Cleveland, OH, 3/8" tilt, model number 4535604 34811, 3/4"tilt, model number 4535674 34801, and 3/8" fixed, model number 4535604 34781, all catalog number 882480 Medical device-- intended to produce images depicting anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.

    Reason

    Unexpected movement-- if the drive assembly is severely compromised, the detector may slide to its hardware limit.

    Action

    Firm initiated its recall notification on July 6, 2009 issuing a field safety notice to its consignees via FedEx and internationally through its personnel. Responses will be tracked for effectiveness. Questions may be directed to Philips Customer Care Center at 1.800.722.9377.

    Distribution

    Worldwide

    Quantity

    288 units