BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated February 14, 2024

    Recall

    Recall Number
    Z-1141-2024
    Event Number
    93962
    Firm
    HeartSine Technologies Ltd 207 Airport Road West Belfast United Kingdom
    FEI Number
    3004123209
    Product Code
    MKJ
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    February 14, 2024
    Posted
    February 15, 2024

    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.

    Action

    On 2/14/24, correction notices were mailed to customers who were asked to do the following: 1) Maintain awareness of this communication internally until the required action has been completed within your facility. 2) Inform the recalling firm if any of the subject devices were distributed to other organizations. The firm will work with you to ensure recipients are notified appropriately. 3) Complete and return the acknowledgment form to [email protected] Upon receipt of the acknowledgment form, the firm will provide instructions on next steps including device replacement. If you have any questions or concerns, please contact the firm's Customer Support at +44 28 9093 9400, 9:00 A.M. to 5:00 P.M. (GMT), Monday - Friday or by email at [email protected].

    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