BEUDAMED
    FDA Recall Terminated

    Prism 3000S and 3000XP Gamma Camera Systems, Models N210060 and N210335.

    Recall: Z-0563-03 · Initiated January 23, 2003

    Recall

    Recall Number
    Z-0563-03
    Event Number
    25518
    Firm
    Philips Medical Systems Inc
    FEI Number
    1525965
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 23, 2003
    Posted
    February 21, 2003
    Terminated
    October 29, 2008
    Address
    595 Miner Rd, Cleveland, OH, 44143

    Description

    Prism 3000S and 3000XP Gamma Camera Systems, Models N210060 and N210335.

    Reason

    The radius motion may exceed the hardware limits, resulting in the detector head to drop towards the patient.

    Action

    The firm mailed a ''Customer Advisory Notice'' to all affected customers on 1/23/2003.

    Distribution

    The sytems were shipped to end-users located nationwide and worldwide.

    Quantity

    311 units