BEUDAMED
    FDA Recall Terminated

    ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate (MI), Italy.

    Recall: Z-1041-2007 · Initiated May 15, 2007

    Recall

    Recall Number
    Z-1041-2007
    Event Number
    37969
    Firm
    Abbott Laboratories, Inc
    FEI Number
    1628664
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 15, 2007
    Posted
    July 3, 2007
    Terminated
    November 27, 2007
    Address
    1921 Hurd Drive PO Box 152020, Irving, TX, 75038

    Description

    ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate (MI), Italy.

    Reason

    Product's hinged lid can fall, if not fully opened as designed, representing a potential injury hazard to the operator.

    Action

    Firm notified consignee via letter on 05/15/07. Consignee informed of potential for injury and advised that a label would be affixed to the device lid by an Abbott representative.

    Distribution

    Device distributed to a hospital in UT.

    Quantity

    1 unit.