BEUDAMED
    FDA Recall Terminated

    biphasic LIFEPAK 500 automated external defibrillators (AEDs) with software version 4.4 or lower; Part Nos. 3011790-XXXXXX, D3100790-XXXXXX, and U3011790-XXXXXX . (XXXX indicates various non-contiguous numbers)

    Recall: Z-1148-2007 · Initiated June 13, 2007

    Recall

    Recall Number
    Z-1148-2007
    Event Number
    38232
    Firm
    Medtronic Emergency Response Systems, Inc.
    FEI Number
    3015876
    Product Code
    MKT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 13, 2007
    Posted
    August 4, 2007
    Terminated
    March 20, 2011
    Address
    11811 Willows Rd Ne, Redmond, WA, 98052-2003

    Description

    biphasic LIFEPAK 500 automated external defibrillators (AEDs) with software version 4.4 or lower; Part Nos. 3011790-XXXXXX, D3100790-XXXXXX, and U3011790-XXXXXX . (XXXX indicates various non-contiguous numbers)

    Reason

    Reduced Shock- the device may deliver 100 Joule (J) to a patient, which is less than the recommended factory minimum default setting of 200 J.

    Action

    On June 13, 2007 the recalling firm sent a letter dated June 11, 2007, titled URGENT - MEDICAL DEVICE CORRECTIVE ACTION. The letter advises of the situation, recommends to the consignee to set defibrillator to FIXED Sequence Protocol and to contact the firm for a FLEXIBLE Sequence Energy Protocol. The letter provides an instruction sheet and a response sheet to be faxed back to the company.

    Distribution

    Worldwide

    Quantity

    59,996 devices