BEUDAMED
    FDA Recall Terminated

    Powerheart G5 Automatic AED

    Recall: Z-1938-2019 · Initiated June 4, 2019

    Recall

    Recall Number
    Z-1938-2019
    Event Number
    83103
    Firm
    Cardiac Science Corporation
    FEI Number
    2112020
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 4, 2019
    Terminated
    November 15, 2021
    Address
    500 Burdick Pkwy, Deerfield, WI, 53531-9692

    Description

    Powerheart G5 Automatic AED

    Reason

    Sub-supplier s documentation for specific Printed Circuit Boards (PCB) is insufficient to determine if the devices conform to specifications.

    Action

    Cardiac Science Corporation notified customers of the recall on about 06/04/2019 via phone call and "URGENT: VOLUNTARY MEDICAL DEVICE RECALL" letter. Customers were instructed to examine inventory, remove any affected devices, and contact Cardiac Science immediately to arrange for return of affected devices and replacement of new devices. Contact can be made by phone to 800.426.0337 option 1 or by email at [email protected]. Distributors were instructed to determine who received the affected devices, inform customers that a Cardiac Science representative will contact them and provided a list with customer names, contact information (including phone and email addresses) and affected device serial numbers to Cardiac Science. The list can be provided by calling 800.426.0337 or by emailing it to [email protected].

    Distribution

    US distribution to Georgia, Texas, and Wisconsin.

    Quantity

    5 devices