BEUDAMED
    FDA Recall Terminated

    SCOPIX LR 5200P Laser Imagers, Type 8394/600, serial numbers between 4000 and 5266.

    Recall: Z-0207-04 · Initiated November 25, 2003

    Recall

    Recall Number
    Z-0207-04
    Event Number
    27844
    Firm
    AGFA Corp.
    FEI Number
    3001236302
    Product Code
    LMC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 25, 2003
    Posted
    December 11, 2003
    Terminated
    October 1, 2004
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    Description

    SCOPIX LR 5200P Laser Imagers, Type 8394/600, serial numbers between 4000 and 5266.

    Reason

    The GS1 circuit board may fail resulting in smoke or fire.

    Action

    Consignees were notified by letter on 11/25/2003. They were informed of the problem and were advised, if they have the affected type and serial number, to contact the Agfa service representative to arrange for repair. The firm intends to install a modified circuit board on each machine remaining in operation at customer locations. Consignees were instructed to discontinue use of the device immediately and to disconnect the unit from the power supply if any odor of smoke or fire is detected. They were urged to complete the Customer Acknowledgement form included with the letter and return it in the enclosed postage paid envelope.

    Distribution

    The units were distributed to hospitals and other health facilities located nationwide

    Quantity

    The units were distributed to hospitals and other health facilities located nationwide