BEUDAMED
    FDA Recall Terminated

    LIFEPAK 20 external defibrillator/monitor

    Recall: Z-1502-06 · Initiated August 30, 2006

    Recall

    Recall Number
    Z-1502-06
    Event Number
    36190
    Firm
    Medtronic Emergency Response Systems, Inc.
    FEI Number
    3015876
    Product Code
    LDD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 30, 2006
    Posted
    September 13, 2006
    Terminated
    March 25, 2011
    Address
    11811 Willows Rd Ne, Redmond, WA, 98052-2003

    Description

    LIFEPAK 20 external defibrillator/monitor

    Reason

    Devices with v38 system software do not display a ''LOW BATTERY: CONNECT TO AC POWER'' message when the monitor is on backup (DC) battery power and may shut down without warning.

    Action

    On August 30, 2006 the firm issued a letter dated August 2006 and titled MEDICAL DEVICE CORRECTION. The letter advises of the issue, explains how to resume power if power is shut down without warning, and advsies that a service representative will contact the consignee to make arrangements to install new software. On 10/19/06 the firm mailed an identical letter dated October 2006 to customers for units that were later identified as being subject to the recall.

    Distribution

    Units were distributed worldwide to hospitals and medical centers.

    Quantity

    2,831 worldwide