HeartSine samaritan PAD — Class II medical device recall Z-1141-2024
Ongoing recall by HeartSine Technologies Ltd, reported 2024-02-21, distributed nationwide. Automated external defibrillators were shipped in their test configuration so there is a potential to have inc
| Recall number | Z-1141-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | HeartSine Technologies Ltd, Belfast, N/A, United Kingdom |
| Recall initiated | 2024-02-14 |
| Classified | 2024-02-15 |
| Reported by FDA | 2024-02-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP, NL, NZ |
| Quantity | 12 |
| UPC / GTIN / UDI-DI | 05060167120671, 05060167122453, 05060167122927, 05060167127311, 05060167127670, 05060167127687, 05060167129773 |
| Serial numbers | 05060167127311, 05060167127670, 18D00020508, 18G00001553, 19D00017655, 20D00006524, 21D91081653, 22D91152391, 23E90001379, 23E90010409, 350P/05060167120671, 360P/05060167127687, 450P/05060167129773, 5060167122927/21E91049810 |
| Model numbers | 350-STR-UK-10, 350-STR-US-10, 350P/350-UNIT-US-10 |
Product
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1141-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.