FDA Device recall Z-1318-2025
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80C, (2) G5A-80C-TSO. Software Version: NA Product Descripti…
- 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-80C, (2) G5A-80C-TSO. Software Version: NA Product Descripti… 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-1318-2025 |
| 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-80C, (2) G5A-80C-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-80C, (2) G5A-80C-TSO; UDI-DI: (1) 00812394021208, (2) 00812394021406; Serial Numbers: (1)…Model/Catalog Number: (1) G5A-80C, (2) G5A-80C-TSO; UDI-DI: (1) 00812394021208, (2) 00812394021406; Serial Numbers: (1) D00000022708, D00000033165, D00000033168, D00000033171, D00000033174, D00000033185, D00000033187, D00000033189, D00000033191, D00000033208, D00000033209, D00000033211, D00000033213, D00000033214, D00000033216, D00000033217, D00000033219, D00000033220, D00000033221, D00000033222, D00000033230, D00000035201, D00000035208, D00000035246, D00000035445, D00000035512, D00000035517, D00000035521, D00000035523, D00000035524, D00000035525, D00000035528, D00000035530, D00000035532, D00000035534, D00000035536, D00000035538, D00000035539, D00000035542, D00000035544, D00000035546, D00000035548, D00000035549, D00000035554, D00000035558, D00000035560, D00000035562, D00000035584, D00000035585, D00000035588, D00000035589, D00000035591, D00000035594, D00000035595, D00000035599, D00000035601, D00000035603, D00000035605, D00000035607, D00000035610, D00000035614, D00000035825, D00000035839 |
|---|
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-1318-2025%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.