BEUDAMED
    FDA Enforcement Class I Terminated

    GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005. . Product Usage: Usage: Skintact Pediatric Multifunction Electrodes are for use on pediatric patients, less than 8 years of age, or weighing less than 25 kg (55 lbs), for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and for single use only.

    Recall: Z-0802-2015 · Reported December 31, 2014

    Enforcement

    Recall Number
    Z-0802-2015
    Event ID
    69930
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Leonhard Lang Gmbh
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 31, 2014
    Initiation Date
    December 3, 2014
    Classification Date
    December 19, 2014
    Termination Date
    August 13, 2015
    Address
    Archenweg 56, Innsbruck, N/A, Austria

    Description

    GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005. . Product Usage: Usage: Skintact Pediatric Multifunction Electrodes are for use on pediatric patients, less than 8 years of age, or weighing less than 25 kg (55 lbs), for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and for single use only.

    Reason

    The firm discovered that during the use of these defibrillation electrodes a possibility for arcing and a resulting malfunction exists. This could lead to a situation, in which a patient who is in a life threatening situation requiring a defibrillation can receive such therapy only with a delay or not at all.

    Code Info

    Lots: 30618-0771, 30702-0778, 40217-0776, 40407-0777, 40424-0772, 40704-0775

    Distribution

    US Nationwide Distribution in the states of OH and TX.

    Quantity

    1080 pieces