BEUDAMED
    FDA Enforcement Class II Terminated

    Skintact ECG Electrode FS-50, Catalog no. 58028 , & Stable Base ECG Electrode SBT-60, Catalog no. 50547. To acquire and transmit the electrical signal at the body surface to a processor that produces an electrocardiogram (ECG) or vectorcardiogram.

    Recall: Z-1350-2015 · Reported April 8, 2015

    Enforcement

    Recall Number
    Z-1350-2015
    Event ID
    70704
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Leonhard Lang Medizintechnik GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 8, 2015
    Initiation Date
    February 24, 2015
    Classification Date
    March 27, 2015
    Termination Date
    July 26, 2017
    Address
    Archenweg 56, N/A, Innsbruck, N/A, N/A, Austria

    Description

    Skintact ECG Electrode FS-50, Catalog no. 58028 , & Stable Base ECG Electrode SBT-60, Catalog no. 50547. To acquire and transmit the electrical signal at the body surface to a processor that produces an electrocardiogram (ECG) or vectorcardiogram.

    Reason

    The electrodes may fail to transmit signals.

    Code Info

    FS-50 Lot: 40120-0093 FS-50 Lot: 40117-0091 FS-50 Lot: 40116-0099 T -60 Lot: 40116-0323 T-60 Lot: 40120-0326 T -60 Lot: 40120-0154 T -60 Lot: 40117-0325 T -60 Lot: 40117-0153 T -60 Lot: 40116-0152 T -60 Lot: 40115-0322

    Distribution

    Distributed to FL.

    Quantity

    364,800