BEUDAMED
    FDA Enforcement Class II Ongoing

    HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-10; SAM 360P/360-STR-JA-10, 360-STR-DE-10, 360-STR-UK-10; SAM 450P/450-UNIT-US-08, ; SAM 500P/500-BAS-UK-10

    Recall: Z-1141-2024 · Reported February 21, 2024

    Enforcement

    Recall Number
    Z-1141-2024
    Event ID
    93962
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    HeartSine Technologies Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 21, 2024
    Initiation Date
    February 14, 2024
    Classification Date
    February 15, 2024
    Address
    207 Airport Road West, N/A, Belfast, N/A, N/A, United Kingdom

    Description

    HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-10; SAM 360P/360-STR-JA-10, 360-STR-DE-10, 360-STR-UK-10; SAM 450P/450-UNIT-US-08, ; SAM 500P/500-BAS-UK-10

    Reason

    Automated external defibrillators were shipped in their test configuration so there is a potential to have incorrect language, and CPR duration resulting in the device prompting users to perform CPR for 5-seconds, and it could analyze heart rhythm and instruct users to deliver a shock every 5-seconds if a shockable heart rhythm is detected, potentially leading to no therapy or delayed therapy.

    Code Info

    Type/UDI-DI or GTIN/Serial Number: SAM 350P/05060167120671, 05060167127670, +M727SAM350P0/$$+7/17D00023014, 18D00020508, 19D00017655, 20D00006524, 21D91081653, 22D91152391; SAM 360P/05060167127687, 05060167127311,5060167122927/21E91049810, 23E90001379, 23E90010409; SAM 450P/05060167129773, +M727SAM450P0/$$+7, +M727SAM450P0/$$+7/17G00001893, 18G00001553; SAM 500P/05060167122453/22B91071233

    Distribution

    Worldwide - US Nationwide distribution in the states of TX, CA, IL, CO, FL, NC, MI and the countries of Netherlands, Japan, New Zealand.

    Quantity

    12