ZOLL Medical Corporation: Device Recall

Recall #Z-1316-2025 · 02/13/2025

Class II: Risk

Recall Details

Recall Number: Z-1316-2025
Classification: Class II
Product Type: Device
Recalling Firm: ZOLL Medical Corporation
Status: Ongoing
Date Initiated: 02/13/2025
Location: Chelmsford, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2268 units

Reason for Recall

The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

Product Description

Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A-03A, (5) G5A-19A, (6) G5A-80A, (7) G5A-80A-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.

Distribution Pattern

Domestic: Nationwide Distribution International: AE, AI, AM, AR, AT, AU, BD, BE, BG, BH, BM, BN, BS, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DO, EG, ES, FI, FR, GB, GH, GU, HK, HR, HU, ID, IE, IL, IN, IS, IT, JE, JM, JP, KR, KW, KZ, LB, LT, MA, MC, MD, ME, MQ, MS, MT, MX, MY, NC, NG, NL, NO, NZ, OM, PA, PE, PG, PH, PK, PL, PR, PT, QA, RE, RO, RS, RU, SA, SE, SG, SI, SK, SM, TC, TH, TN, TR, TW, UA, US, VG, ZA.

Other Recalls by ZOLL Medical Corporation

Class II: Risk 02/13/2025

The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Class II: Risk 02/13/2025

The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Class II: Risk 02/13/2025

The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Class II: Risk 02/13/2025

The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Class II: Risk 02/13/2025

The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

View all recalls by ZOLL Medical Corporation →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.