FDA Device recall Z-1316-2025
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A-03A, (5) G5A-19A, (6)…
- FDA Device
- Class II
- ongoing
- Published 2025-03-19
On 2025-03-19 the FDA classified a Class II recall of Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A-03A, (5) G5A-19A, (6)… by Zoll Medical, citing the potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1316-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-13 |
| Published | 2025-03-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Zoll Medical |
| Distribution | US |
Product
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A-03A, (5) G5A-19A, (6) G5A-80A, (7) G5A-80A-TSO. Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas.
Reason
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Identifiers
| code_info | Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A-03A, (5) G5A-19A, (6) G5A-80A, (7) G5A-80A-TSO; UD…Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A-03A, (5) G5A-19A, (6) G5A-80A, (7) G5A-80A-TSO; UDI-DI: (1) no UDI, (2) 00812394021154, (3) no UDI, (4) no UDI, (5) 00812394022243, (6) 00812394021192, (7) 00812394021390; Serial Numbers: (1) D00000177884, D00000177917, D00000177931, D00000177956, D00000178271, D00000178311, D00000178395, D00000178542, M00000002041, M00000008225, M00000008290, M00000008336, (2) D00000003482, D00000003546, D00000003557, D00000003600, D00000003625, D00000003783, D00000003978, D00000003983, D00000003985, D00000004036, D00000004037, D00000004040, D00000004043, D00000004089, D00000004098, D00000004100, D00000004105, D00000004107, D00000004109, D00000004111, D00000004116, D00000004118, D00000004119, D00000004120, D00000004123, D00000004129, D00000004131, D00000004132, D00000004133, D00000004138, D00000004140, D00000004141, D00000004142, D00000004143, D00000004145, D00000004146, D00000004147, D00000004148, D00000004150, D00000004155, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1316-2025%22
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