Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibri...
FDA Device Recall #Z-1217-2023 — Class II — February 1, 2023
Recall Summary
| Recall Number | Z-1217-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 1, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | HeartSine Technologies Ltd |
| Location | Belfast |
| Product Type | Devices |
| Quantity | 13 |
Product Description
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.
Distribution Pattern
US: NJ, PA, WI, NE, TX, PA, CA, AZ, AR OUS: Australia, Czechia, Canada, New Zealand
Lot / Code Information
REF/UDI-DI/Serial Numbers: SAM 350P/05060167120671/17D00006810, 19D00027547, 19D00030364, 20D00000454, 20D00000868, 20D00006232, 22D91125401, 16D01000729, 22D91145062; SAM 360P/5060167127120, 5060167128028/20E90006314, 21E91040881; SAM 500P/5060167126505, 5060167125843/17B00003113, 20B90000080
Other Recalls from HeartSine Technologies Ltd
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0288-2026 | Class II | HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02,... | Sep 18, 2025 |
| Z-2174-2025 | Class II | HeartSine SAM 350P, HeartSine SAM 360P, and Hea... | Jun 30, 2025 |
| Z-1820-2024 | Class II | HeartSine samaritan PAD (Public Access Defibril... | Apr 8, 2024 |
| Z-1141-2024 | Class II | HeartSine samaritan PAD (Public Access Defibril... | Feb 14, 2024 |
| Z-2143-2023 | Class II | HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD... | Apr 26, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.