BEUDAMED
    FDA Recall Terminated

    PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2603H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR

    Recall: Z-0459-2015 · Initiated November 6, 2014

    Recall

    Recall Number
    Z-0459-2015
    Event Number
    69752
    Firm
    ConMed Corporation
    FEI Number
    3001451571
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 6, 2014
    Posted
    December 4, 2014
    Terminated
    October 30, 2017
    Address
    525 French Rd, Utica, NY, 13502-5945

    Description

    PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2603H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR

    Reason

    Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death or serious injury.

    Action

    ConMed sent an Urgent Device Correction letter dated November 16, 2014, to all affected consignees via UPS Next Day Air. The letter instructed consignees to notify all end users of the correction. For questions or additional information, consignees were instructed to contact ConMed at 1-727-399-5276 or by e-mail at [email protected]. International notices were sent via UPS Priority or equivalent by November 19, 2014.

    Distribution

    Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Bosnia, Herzegovina, Brazil, Canada, Great Britain, Israel, Italy, Republic of Korea, Norway, Portugal, Saudi Arabia, and Spain.

    Quantity

    174,610 (168,090 US and 6,520 OUS) in total.