Class 2 Device Recall ZOLL Powerheart G5

• Date Initiated by Firm: February 13, 2025
• Date Posted: March 12, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1316-2025
• Recall Event ID: 96198
• PMA Number: P160033
• Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ
• 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.
• Code Information: 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, D00000004150, 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• Recalling Firm/ Manufacturer: ZOLL Medical Corporation; 269 Mill Rd; Chelmsford MA 01824-4105
• For Additional Information Contact: Paul Dias; 1-978-4219011
• Manufacturer 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 Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = MKJ