BEUDAMED
    FDA Enforcement Class II Terminated

    HeartStart XL+ Defibrillator/Monitor, Model 861290

    Recall: Z-0608-2020 · Reported December 11, 2019

    Enforcement

    Recall Number
    Z-0608-2020
    Event ID
    84236
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips North America, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 11, 2019
    Initiation Date
    October 3, 2019
    Classification Date
    December 5, 2019
    Termination Date
    April 19, 2023
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032, United States

    Description

    HeartStart XL+ Defibrillator/Monitor, Model 861290

    Reason

    Device may fail to turn on or unexpectedly attempt to restart, rendering it unable to return to a ready for use state. Additionally, this issue may occur when the device is in standby mode, when attempting to power on to run a self-test. If this occurs, the device will indicate that it is not ready for use.

    Code Info

    All Units, Model number 861290

    Distribution

    US Nationwide

    Quantity

    24,738 units