Z-1316-2025Class II

Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A...

Name: Z-1316-2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A...
Creator: ZOLL Medical Corporation
Published: 2025-02-13
License: https://open.fda.gov/license/

ZOLL Medical Corporation / initiated 2025-02-13 / Open, Classified

FDA source

ZOLL Medical Corporation began a recall of 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)... on 2025-02-13. FDA classified it as Class II and gives the reason as "The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity)". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1316-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-13
Posted: 2025-03-12
Recalling firm: ZOLL Medical Corporation
Product: 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.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
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).
FDA root cause: Unknown/Undetermined by firm
Action: On February 13, 2025, URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers. REQUIRED ACTIONS Customers who have AEDs should routinely: (1) Monitor device for self-test results. (2) For customers who experience a self-test failure, take action to resolve any alerts as soon as possible. Customers who have at-risk devices should immediately: (1) Communicate this notification to G5 AED users. (2) Ensure users have a program in place that periodically monitors the status of these devices, in accordance with G5 User s Guide. (3) EC 501 is likely due to exposure to humidity outside the device s published specification. Ensure devices are stored within the device s published specifications: " Temperature: 0C to 50C (32F to 122F) " Humidity: 10% to 95% (non-condensing) (4) Respond to ZOLL via the customer notification form acknowledging that you have received this notice. We have notified the appropriate regulatory agencies of this correction and expect it to be classified as a recall. We apologize for any inconvenience this may cause you and thank you in advance for assistance in implementing this correction. Ensuring these devices are rescue ready is our highest priority. Our 24/7 technical support numbers 1 (800) 348-9011 or 1 (978) 421-9460 and are available to assist users with any aspect of this notice. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax with the fax number being 1-800-FDA-0178.
Quantity in commerce: 2268 units
Distribution: 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.
Product codes and lots: 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; UDI-DI: (1) no UDI, (2) 00812394021154, (3) no UDI, (4) no UDI, (5) 00812394022243, (6) 00812394021192, (7) 00812394021390; Serial Numbers: (1) D00000177884, D00000177917, D00000177931, D00000177956, D00000178271, D00000178311, D00000178395, D00000178542, M00000002041, M00000008225, M00000008290, M00000008336, (2) D00000003482, D00000003546, D00000003557, D00000003600, D00000003625, D00000003783, D00000003978, D00000003983, D00000003985, D00000004036, D00000004037, D00000004040, D00000004043, D00000004089, D00000004098, D00000004100, D00000004105, D00000004107, D00000004109, D00000004111, D00000004116, D00000004118, D00000004119, D00000004120, D00000004123, D00000004129, D00000004131, D00000004132, D00000004133, D00000004138, D00000004140, D00000004141, D00000004142, D00000004143, D00000004145, D00000004146, D00000004147, D00000004148, 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D00000243594, D00000243601, D00000243602, D00000243604, D00000243605, D00000243606, D00000243608, D00000243610, D00000243617, D00000243629, D00000243637, D00000243640, D00000243641, D00000243644, D00000243645, D00000243647, D00000243650, D00000243661,

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1316-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1316-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-19	2025-03-12
Z-1317-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-19	2025-03-12
Z-1318-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-19	2025-03-12
Z-1319-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-19	2025-03-12
Z-1320-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-19	2025-03-12
Z-1321-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-19	2025-03-12
Z-1322-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-19	2025-03-12
Z-1323-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-19	2025-03-12

Product code MKJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)