BEUDAMED
    FDA Enforcement Class I Terminated

    ADULT Radiotranslucent Electrode, Part number T100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.

    Recall: Z-0586-2015 · Reported December 31, 2014

    Enforcement

    Recall Number
    Z-0586-2015
    Event ID
    69875
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Heart Sync, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 31, 2014
    Initiation Date
    November 11, 2014
    Classification Date
    December 23, 2014
    Termination Date
    November 24, 2015
    Address
    5643 Plymouth Rd, Ann Arbor, MI, 48105-9586, United States

    Description

    ADULT Radiotranslucent Electrode, Part number T100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.

    Reason

    Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. The FR3, however, does not require pre-connection and the user may not discover the incompatibility issue until the

    Code Info

    All Lots. Catalog / Part Number T100-PHILIPS

    Distribution

    Worldwide Distribution - USA (Nationwide) in the states of NM, VT, MN, IL, MO, OH, MI, OR, ND, KY, PA, TX, WA, FL, NE, AR, VA, DE, GA, NY, CA, TN, AZ, RI, MA, and PR; and countries of: Thailand and South Korea.

    Quantity

    sold in boxes of ten electrodes: 4692.9 boxes; 46929 units total