BEUDAMED
    FDA Recall Terminated

    LIFEPAK 12 defibrillator/ monitors biphasic

    Recall: Z-0495-05 · Initiated January 15, 2005

    Recall

    Recall Number
    Z-0495-05
    Event Number
    30915
    Firm
    Medtronic Emergency Response Systems, Inc.
    FEI Number
    3015876
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 15, 2005
    Posted
    February 3, 2005
    Terminated
    May 6, 2006
    Address
    11811 Willows Rd Ne, Redmond, WA, 98052-2003

    Description

    LIFEPAK 12 defibrillator/ monitors biphasic

    Reason

    The LIFEPAK 12 biphasic defibrillator/ monitors may deliver inappropriate energy levels and fail to escalate energy levels when configured to do so.

    Action

    The firm sent 4000 User Notification letters via FED-EX on 1/15/2005 and approximately 3000 on 1/17/2005. The User Notification letters informed consignees about the two complaints and described the firm''s findings from their investigation into the problem. The letters also requested the users check the default energy settings; report back to the firm any discrepancies found; and reset the discrepant settings which differed from the user programmed settings.

    Distribution

    28,835 devices were shipped to 6874 domestic consignees.

    Quantity

    28,835 devices distributed in the U.S.; 15,613 devices distributed internationally