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Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2) G5A-02C...

FDA Device Recall #Z-1319-2025 — Class II — February 13, 2025

Recall Summary

Recall Number Z-1319-2025
Classification Class II — Moderate risk
Date Initiated February 13, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm ZOLL Medical Corporation
Location Chelmsford, MA
Product Type Devices
Quantity 960 units

Product Description

Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-08C, (5) G5A-10C, (6) G5A-13C, (7) G5A-15C, (8) G5A-22C, (9) G5A-41C, (10) G5A-85C, (11) G5A-90C (12) G5A-80-L; 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 for Recall

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

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.

Lot / Code Information

Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-08C, (5) G5A-10C, (6) G5A-13C, (7) G5A-15C, (8) G5A-22C, (9) G5A-41C, (10) G5A-85C, (11) G5A-90C (12) G5A-80-L; UDI-DI: (1) 00812394021161, (2) no UDI, (3) no UDI, (4) no UDI, (5) no UDI, (6) no UDI, (7) no UDI, (8) no UDI, (9) no UDI, (10) 00812394021208 (11) no UDI, (12) 00812394021215; Serial Numbers: (1) D00000066618, D00000066630, D00000066659, D00000066773, D00000067078, D00000067079, D00000067081, D00000067082, D00000067086, D00000067088, D00000067092, D00000067094, D00000067097, D00000067099, D00000067100, D00000067103, D00000067108, D00000067109, D00000067114, D00000067117, D00000067129, D00000067133, D00000067135, D00000067136, D00000067138, D00000067139, D00000067143, D00000067145, D00000067171, D00000067172, D00000067174, D00000067178, D00000067180, D00000067183, D00000067184, D00000067186, D00000067192, D00000067195, D00000067197, D00000067199, D00000067204, D00000067209, D00000067212, D00000067217, 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D00000275097, D00000275124, D00000275152, D00000275153, D00000275154, D00000275155, D00000275156, D00000275158, D00000275159, D00000275160, D00000275161, D00000275169, D00000275170, D00000275171, D00000275183, D00000275185, D00000275186, D00000275189, D00000275190, D00000275191, D00000275195, D00000275198, D00000275200, D00000275201, D00000275202, D00000275203, D00000275205, D00000275206, D00000275207, D00000275208, D00000275212, D00000275215, D00000275219, D00000275220, D00000275221, D00000275222, D00000275223, D00000275230, D00000275231, D00000275232, D00000275233, D00000275234, D00000275235, D00000275237, D00000275241, D00000275242, D00000275246, D00000275248, D00000275249, D00000275250, D00000275251, D00000275252, D00000275253, D00000275254, D00000275255, D00000275256, D00000275257, D00000275258, D00000275261, D00000275262, D00000275263, D00000275264, D00000275271, D00000275274, D00000275275, D00000275277, D00000275278, D00000275281, D00000275283, D00000275285, D00000275286, 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D00000158547, D00000158549, D00000158620, D00000158646, D00000158656, D00000158661, D00000158678, D00000158682, D00000158685, D00000158712, D00000158716, D00000158717, D00000158723, (3) D00000169508, (4) D00000112016, D00000120996, D00000120997, D00000158450, D00000158480, D00000158489, D00000158555, D00000158562, D00000158681, D00000158700, D00000158839, D00000158841, D00000158845, D00000158846, D00000158848, D00000158849, D00000158852, D00000158863, D00000158865, D00000158866, D00000158874, D00000158887, D00000158890, D00000158897, D00000158900, D00000158903, D00000158905, D00000158907, D00000158912, D00000158918, D00000158934, D00000158937, D00000158938, D00000158942, D00000184320, M00000008557, (5) D00000171663, D00000171665, D00000171666, D00000171788, D00000171789, (6) D00000158867, D00000158877, D00000158880, D00000158889, (7) D00000158524, D00000158563, D00000158584, D00000158598, D00000158613, D00000158614, D00000178683, (8) D00000158894, D00000158923, D00000158975, 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Other Recalls from ZOLL Medical Corporation

Recall # Classification Product Date
Z-1316-2025 Class II Brand Name: ZOLL Product Name: Powerheart G5 A... Feb 13, 2025
Z-1321-2025 Class II Brand Name: ZOLL Product Name: Powerheart G5 A... Feb 13, 2025
Z-1317-2025 Class II Brand Name: ZOLL Product Name: Powerheart G5 A... Feb 13, 2025
Z-1318-2025 Class II Brand Name: ZOLL Product Name: Powerheart G5 A... Feb 13, 2025
Z-1320-2025 Class II Brand Name: ZOLL Product Name: Powerheart G5 A... Feb 13, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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