Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator — Class II medical device recall Z-1217-2023
Ongoing recall by HeartSine Technologies Ltd, reported 2023-03-15, distributed in AR, AZ, CA, NE, NJ, PA, TX, WI. Automated external defibrillators were potentially distributed with the incorrect language configuration, whic
| Recall number | Z-1217-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | HeartSine Technologies Ltd, Belfast, United Kingdom |
| Recall initiated | 2023-02-01 |
| Classified | 2023-03-03 |
| Reported by FDA | 2023-03-15 |
| Distributed | AR, AZ, CA, NE, NJ, PA, TX, WI |
| Countries outside the US | AU, CA, CZ, NZ |
| Quantity | 13 |
| UPC / GTIN / UDI-DI | 05060167120671, 05060167125843, 05060167126505, 05060167127120, 05060167128028 |
| Serial numbers | 16D01000729, 19D00027547, 19D00030364, 20B90000080, 20D00000454, 20D00000868, 20D00006232, 21E91040881, 22D91125401, 22D91145062, 360P/5060167127120, 500P/5060167126505, 5060167125843/17B00003113, 5060167128028/20E90006314 |
Product
Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor
Reason for recall
Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no 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-1217-2023. 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.