FDA Device recall Z-1323-2025
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80A
- 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: G5S-80A 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-1323-2025 |
| 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: G5S-80A; 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: G5S-80A; UDI-DI: 00812394021277; Serial Numbers: D00000003974, D00000004048, D00000004128, D00000…Model/Catalog Number: G5S-80A; UDI-DI: 00812394021277; Serial Numbers: D00000003974, D00000004048, D00000004128, D00000004404, D00000004436, D00000004556, D00000004560, D00000004563, D00000004564, D00000004573, D00000004581, D00000004582, D00000004642, D00000004665, D00000004666, D00000004718, D00000004730, D00000004736, D00000004743, D00000004744, D00000004750, D00000004770, D00000004774, D00000004779, D00000004780, D00000004784, D00000004785, D00000004787, D00000004789, D00000004794, D00000004799, D00000004800, D00000004801, D00000004802, D00000004805, D00000004806, D00000004807, D00000004808, D00000004809, D00000004810, D00000004812, D00000004815, D00000004816, D00000004818, D00000004820, D00000004821, D00000004824, D00000004873, D00000004916, D00000004929, D00000004933, D00000004939, D00000004940, D00000004951, D00000004955, D00000004960, D00000004970, D00000004974, D00000004976, D00000004983, D00000006293, D00000006294, D00000006296, D00000006338, D00000006341, D00000006343, 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-1323-2025%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.