BEUDAMED
    FDA Enforcement Class II Ongoing

    Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor

    Recall: Z-1217-2023 · Reported March 15, 2023

    Enforcement

    Recall Number
    Z-1217-2023
    Event ID
    91659
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    HeartSine Technologies Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 15, 2023
    Initiation Date
    February 1, 2023
    Classification Date
    March 3, 2023
    Address
    207 Airport Road West, Belfast, N/A, United Kingdom

    Description

    Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor

    Reason

    Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy.

    Code Info

    REF/UDI-DI/Serial Numbers: SAM 350P/05060167120671/17D00006810, 19D00027547, 19D00030364, 20D00000454, 20D00000868, 20D00006232, 22D91125401, 16D01000729, 22D91145062; SAM 360P/5060167127120, 5060167128028/20E90006314, 21E91040881; SAM 500P/5060167126505, 5060167125843/17B00003113, 20B90000080

    Distribution

    US: NJ, PA, WI, NE, TX, PA, CA, AZ, AR OUS: Australia, Czechia, Canada, New Zealand

    Quantity

    13