Recall Z-1317-2025
ZOLL Medical Corporation · initiated February 13, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80A, (2) 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.
Codes / lots: Model/Catalog Number: (1) G5A-80A, (2) G5A-80A-TSO; UDI-DI: (1) 00812394021192, (2) 00812394021390; Serial Numbers: D00000003715, D00000003785, D00000003909, D00000003916, D00000003920, D00000003937, D00000003940, D00000003946, D00000003948, D00000003953, D00000003969, D00000003975, D00000004007, D00000004008, D00000004009, D00000004010, D00000004012, D00000004014, D00000004016, D00000004017, D00000004018, D00000004020, D00000004023, D00000004024, D00000004025, D00000004027, D00000004028, D00000004029, D00000004030, D00000004032, D00000004033, D00000004034, D00000004035, D00000004038, D00000004039, D00000004041, D00000004042, D00000004044, D00000004045, D00000004047, D00000004049, D00000004050, D00000004051, D00000004052, D00000004053, D00000004054, D00000004055, D00000004056, D00000004057, D00000004079, D00000004097, D00000004103, D00000004106, D00000004108, D00000004122, D00000004124, D00000004127, D00000004134, D00000004135, D00000004136, D00000004137, D00000004139, D00000004144, D00000004195, D00000004198, D00000004200, D00000004202, D00000004210, D00000004212, D00000004218, D00000004222, D00000004223, D00000004228, D00000004232, D00000004236, D00000004237, D00000004239…
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 taken
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.
Details
- Recall number
- Z-1317-2025
- Initiated
- February 13, 2025
- Posted by FDA
- March 12, 2025
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Quantity
- 56,981 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…
- Recalling firm
- ZOLL Medical Corporation, Chelmsford, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1316-2025 Class II | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2)…The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments… | 02/13/2025Open, Classified |
| Z-1318-2025 Class II | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80C, (2)…The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments… | 02/13/2025Open, Classified |
| Z-1319-2025 Class II | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2)…The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments… | 02/13/2025Open, Classified |
| Z-1320-2025 Class II | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2)…The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments… | 02/13/2025Open, Classified |
| Z-1321-2025 Class II | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; Software…The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments… | 02/13/2025Open, Classified |
| Z-1322-2025 Class II | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-00A-TSO…The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments… | 02/13/2025Open, Classified |
| Z-1323-2025 Class II | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80A; Software…The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments… | 02/13/2025Open, Classified |