Brand Name: ZOLL Product Name: Powerheart G5 AED recall
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-11C; Software Version: NA…
Why was Brand Name: ZOLL Product Name: Powerheart G5 AED recalled?
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-11C; UDI-DI: (1) 00812394021246, (2) no UDI, (3) no UDI, (4) no UDI; Serial Numbers: (1) D00000089561, D00000089566, D00000089577, D00000105587, D00000111542, D00000111556, D00000111640, D00000111706, D00000111718, D00000113136, D00000113147, D00000113175, D00000113177, D00000113178, D00000113180, D00000113181, D00000113182, D00000113199, D00000113200, D00000113201, D00000113205, D00000113206, D00000113207, D00000134850, D00000134892, D00000135125, D00000136870, D00000136917, D00000136954, D00000157288, D00000170036, D00000170073, D00000172554, D00000178309, D00000178332, D00000183632, D00000191330, D00000191339, D00000191347, D00000191349, D00000191362, D00000191363, D00000191366, D00000221153, D00000221179, D00000221199, D00000221200, D00000221206, D00000221208, D00000221211, D00000221235, D00000221237, D00000221245, D00000221247, D00000221257, D00000221263, D00000221265, D00000221267, D00000221273, D00000221279, D00000221283, (2)D00000004566, D00000004687, D00000004688, D00000005214, D00000017929, D00000067528, D00000067585, D00000067595, D00000067685, D00000155123, (3) D00000171086, (4) M00000005364;
- Product
- Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-11C; Software Version: NA…
- Recalling firm
- ZOLL Medical Corporation
- Quantity
- 73 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.
- Recall date
- March 19, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)