HeartSine Technologies Ltd
Medical device manufacturer in Belfast, Unit.
6510(k) clearances
1PMA approvals
9recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K142709 | samaritan PAD 450PMKJ · Traditional | 03/27/2015SE |
| K123881 | Heartsine Samaritan Pad 350PMKJ · Traditional | 07/11/2013SE |
| K052465 | Reduced Energy Pediatric Electrode Pads for the Samaritan AED and Pad, Models Sde 251…MKJ · Traditional | 12/12/2006SE |
| K042088 | Samaritan Pad Pak Defibrillation Electrode, Model SPP-301MKJ · Traditional | 09/02/2004SE |
| K041067 | Heartsine Samaritan PadMKJ · Special | 05/25/2004SE |
| K023854 | Samaritan AED, Model SAM-01MKJ · Traditional | 02/14/2003SE |
PMA approvals
- P160008 HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) · 01/12/2017 · 32 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-3120-2026 Class II | HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067…Due to a damaged (over stretched) membrane tail that causes an intermittent fault. | 07/27/2026Open, Classified |
| Z-0288-2026 Class II | HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07…Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and… | 09/18/2025Open, Classified |
| Z-2174-2025 Class II | HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan…Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver… | 06/30/2025Open, Classified |
| Z-1820-2024 Class II | HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450PAutomated external defibrillators have a manufacturing issue that could prevent the device from delivering… | 04/08/2024Open, Classified |
| Z-1141-2024 Class II | HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM…Automated external defibrillators were shipped in their test configuration so there is a potential to have… | 02/14/2024Open, Classified |
| Z-2143-2023 Class II | HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with…Single use battery and electrode cartridge may be rendered inoperable due to depleted battery cells which… | 04/26/2023Open, Classified |
| Z-1217-2023 Class II | Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic…Automated external defibrillators were potentially distributed with the incorrect language configuration… | 02/01/2023Open, Classified |
| Z-2115-2014 Class II | Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device…A small number of sealed foil pouches containing the electrodes were found to be difficult to open… | 06/12/2014Terminated |
| Z-0124-2013 Class I | HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to…Certain Samaritan 300/300P PAD devices may experience one or both of the following conditions that could… | 09/13/2012Terminated |