# P160008: HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)

- Pathway: PMA
- Applicant: Heartsine Technologies, Ltd.
- Decided: Jan 12, 2017 after 297 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Jul 27, 2026 · Class III · Z-3270-2026: Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.
- Jul 27, 2026 · Class II · Z-3120-2026: Due to a damaged (over stretched) membrane tail that causes an intermittent fault.
- Sep 18, 2025 · Class II · Z-0288-2026: Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.
- Jun 30, 2025 · Class II · Z-2174-2025: Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)
- Apr 26, 2023 · Class II · Z-2143-2023: Single use battery and electrode cartridge may be rendered inoperable due to depleted battery cells which could prevent the defibrillator from analyzing patient condition or delivering therapy correct
- Feb 1, 2023 · Class II · Z-1217-2023: Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy.
- Jan 13, 2022 · Class III · Z-0745-2022: Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs.

Source page: https://510kreport.com/device/P160008
Methodology: https://510kreport.com/methodology