FDA Device recall Z-1319-2025
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-08C, (5) G5A-10C, (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-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-08C, (5) G5A-10C, (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-1319-2025 |
| 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-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-08C, (5) G5A-10C, (6) G5A-13C, (7) G5A-15C, (8) G5A-22C, (9) G5A-41C, (10) G5A-85C, (11) G5A-90C (12) G5A-80-L; 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-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-08C, (5) G5A-10C, (6) G5A-13C, (7) G5A-15C, (8) G5…Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-08C, (5) G5A-10C, (6) G5A-13C, (7) G5A-15C, (8) G5A-22C, (9) G5A-41C, (10) G5A-85C, (11) G5A-90C (12) G5A-80-L; UDI-DI: (1) 00812394021161, (2) no UDI, (3) no UDI, (4) no UDI, (5) no UDI, (6) no UDI, (7) no UDI, (8) no UDI, (9) no UDI, (10) 00812394021208 (11) no UDI, (12) 00812394021215; Serial Numbers: (1) D00000066618, D00000066630, D00000066659, D00000066773, D00000067078, D00000067079, D00000067081, D00000067082, D00000067086, D00000067088, D00000067092, D00000067094, D00000067097, D00000067099, D00000067100, D00000067103, D00000067108, D00000067109, D00000067114, D00000067117, D00000067129, D00000067133, D00000067135, D00000067136, D00000067138, D00000067139, D00000067143, D00000067145, D00000067171, D00000067172, D00000067174, D00000067178, D00000067180, D00000067183, D00000067184, D00000067186, D00000067192, D00000067195, D00000067197, D00000067199, D00000067204, D00000067209, D00000067212, D00000067217, D0000 |
|---|
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-1319-2025%22
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