Agency classClass IIOur severity:High FDA (Devices)·Z-1318-2025·Announced 2025-03-19

ZOLL Powerheart G5 AED may fail self-test in extreme environments

ZOLL is recalling certain Powerheart G5 automated external defibrillators (AED) due to the potential for devices to fail their self-test when exposed to extreme temperatures or humidity.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall addresses a potential malfunction in a life-critical cardiac emergency device. The hazard remains theoretical without reported device failures or patient injuries, but the potential consequence of device failure in an emergency situation justifies a High severity rating.

Plain-English summary

ZOLL Medical Corporation is recalling Powerheart G5 automated external defibrillators (AED), models G5A-80C and G5A-80C-TSO. Approximately 63,607 units were distributed domestically throughout the United States and internationally.

The recalled devices have the potential to fail their self-test when exposed to prolonged periods of extreme temperature and/or humidity. This self-test failure could prevent the device from functioning properly in a cardiac emergency.

Patients and healthcare facilities with these AED devices should verify their device serial numbers against the manufacturer's recall information. Contact ZOLL Medical Corporation directly for instructions on device evaluation and any necessary replacement or service.

The recalled product

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…
Manufacturer: ZOLL Medical Corporation
Category: Medical Device
Hazard: self-test-failure
environmental-exposure
Affected units: 63,607

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed nationwide across the United States.

The notice also names 17 states specifically:

Part of a larger recall action

This product is one of 8 recalled by ZOLL Medical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Same manufacturer · ZOLL Medical Corporation

See all →

High
ZOLL Powerheart G5 AED Self-Test May Fail Under Extreme Environmental Conditions
FDA (Devices) · 2025-03-19
High
ZOLL Powerheart G5 AED May Fail Self-Test in Extreme Conditions
FDA (Devices) · 2025-03-19
High
ZOLL Powerheart G5 AED May Fail Self-Test After Environmental Exposure
FDA (Devices) · 2025-03-19
High
ZOLL Powerheart G5 AED devices may fail self-test in extreme environments
FDA (Devices) · 2025-03-19
High
ZOLL Powerheart G5 AED Devices Recalled for Self-Test Failure Risk
FDA (Devices) · 2025-03-19

Same hazard · self test failure