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.