FDA Device recall Z-1322-2025
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4) G5S-05A, (5) G5S-08A,…
- 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) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4) G5S-05A, (5) G5S-08A,… 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-1322-2025 |
| 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) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4) G5S-05A, (5) G5S-08A, (6) G5S-10A, (7) G5S-11A, (8) G5S-80A-TSO, (9) G5S-80-L (10) G5S-90A; 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) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4) G5S-05A, (5) G5S-08A, (6) G5S-10A, (7) G5S-11A, (8…Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4) G5S-05A, (5) G5S-08A, (6) G5S-10A, (7) G5S-11A, (8) G5S-80A-TSO, (9)G5S-80-L, (10) G5S-90A; UDI-DI: (1) no UDI, (2) 00812394021239, (3) no UDI, (4) no UDI, (5) no UDI, (6) no UDI, (7) no UDI, (8) 00812394021413, (9) no UDI, (10) no UDI; Serial Numbers: (1) D00000154575, D00000154617, (2) D00000003725, D00000003727, D00000003734, D00000003896, D00000003898, D00000003923, D00000003927, D00000003941, D00000003943, D00000003951, D00000003955, D00000003962, D00000003964, D00000003965, D00000003968, D00000003971, D00000003972, D00000003981, D00000003982, D00000003984, D00000003987, D00000003989, D00000003991, D00000003997, D00000003999, D00000004149, D00000004151, D00000004153, D00000004154, D00000004156, D00000004158, D00000004301, D00000004304, D00000004308, D00000004313, D00000004324, D00000004329, D00000004365, D00000004390, D00000004394, D00000004402, D00000004407, D00000004408, D00000004410, D00000004413, D000000 |
|---|
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-1322-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.