BEUDAMED
    FDA Enforcement Class II Terminated

    Powerheart¿ G5 Automatic AED

    Recall: Z-1938-2019 · Reported July 10, 2019

    Enforcement

    Recall Number
    Z-1938-2019
    Event ID
    83103
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cardiac Science Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 10, 2019
    Initiation Date
    June 4, 2019
    Classification Date
    July 3, 2019
    Termination Date
    November 15, 2021
    Address
    500 Burdick Pkwy, N/A, Deerfield, WI, 53531-9692, United States

    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.

    Code Info

    Model Number G5A 80A; AED Serial Number (UDI Number): D00000133922 )(01)00812394021222(11)190508(21)D00000133922), D00000133927 ((01)00812394021222(11)190509(21)D00000133927), D00000133930 ((01)00812394021222(11)190509(21)D00000133930), D00000133934 ((01)00812394021222(11)190509(21)D00000133934), D00000133936 )(01)00812394021222(11)190509(21)D00000133936).

    Distribution

    US distribution to Georgia, Texas, and Wisconsin.

    Quantity

    5 devices