# P160033: Powerheart® G5 AED, Powerheart® AED G3 Plus, and Powerheart® AED G3

- Pathway: PMA
- Applicant: ZOLL Medical Corporation
- Decided: Dec 7, 2018 after 856 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 9 (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
- Feb 13, 2025 · Class II · Z-1320-2025: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
- Feb 13, 2025 · Class II · Z-1317-2025: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
- Feb 13, 2025 · Class II · Z-1322-2025: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
- Feb 13, 2025 · Class II · Z-1318-2025: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
- Feb 13, 2025 · Class II · Z-1319-2025: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
- Feb 13, 2025 · Class II · Z-1323-2025: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
- Feb 13, 2025 · Class II · Z-1316-2025: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
- Feb 13, 2025 · Class II · Z-1321-2025: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
- Jun 4, 2019 · Class II · Z-1938-2019: Sub-supplier s documentation for specific Printed Circuit Boards (PCB) is insufficient to determine if the devices conform to specifications.

Source page: https://510kreport.com/device/P160033
Methodology: https://510kreport.com/methodology