Reported Feb 21, 2024 · Ongoing
HeartSine samaritan PAD (Public Access Defibrillator)
HeartSine Technologies Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: HeartSine Technologies Ltd · 207 Airport Road West · Belfast, N/A · N/A
Is this the product you have?
HeartSine samaritan PAD (Public Access Defibrillator)
4 of 4 products
| # | Product as published |
|---|---|
| 1 | Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-10 |
| 2 | SAM 360P/360-STR-JA-10, 360-STR-DE-10, 360-STR-UK-10 |
| 3 | SAM 450P/450-UNIT-US-08 |
| 4 | SAM 500P/500-BAS-UK-10 |
- Lot codes and dates
4 of 4 products
Products covered by this recall # Barcodes Product as published 1 0506016712067105060167127670Type/UDI-DI or GTIN/Serial Number: SAM 350P/05060167120671, 05060167127670, +M727SAM350P0/$$+7/17D00023014, 18D00020508, 19D00017655, 20D00006524, 21D91081653, 22D91152391 2 05060167127687050601671273115060167122927SAM 360P/05060167127687, 05060167127311,5060167122927/21E91049810, 23E90001379, 23E90010409 3 05060167129773SAM 450P/05060167129773, +M727SAM450P0/$$+7, +M727SAM450P0/$$+7/17G00001893, 18G00001553 4 05060167122453SAM 500P/05060167122453/22B91071233 - Amount recalled
- 12
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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