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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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, 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- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- ZOLL Medical Corporation
- 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).
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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, 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D00000010210, D00000010211, D00000010213, D00000010215, D00000010216, D00000010217, D00000010218, D00000010219, D00000010220, D00000010222, D00000010223, D00000010224, D00000010225, D00000010226, D00000010228, D00000010229, D00000010230, D00000010231, D00000010232, D00000010233, D00000010234, D00000010236, D00000010237, D00000010239, D00000010240, D00000010241, D00000010242, D00000010243, D00000010244, D00000010245, D00000010247, D00000010250, D00000010318, D00000010320, D00000010321, D00000010322, D00000010323, D00000010324, D00000010325, D00000010326, D00000010327, D00000010328, D00000010329, D00000010330, D00000010331, D00000010332, D00000010333, D00000010334, D00000010335, D00000010336, D00000010337, D00000010338, D00000010339, D00000010340, D00000010341, D00000010342, D00000010343, D00000010344, D00000010345, D00000010346, D00000010347, D00000010348, D00000010349, D00000010350, D00000010351, D00000010355, D00000010356, D00000010357, D00000010358, D00000010359, D00000010360, D00000010362, D00000010363, D00000010364, D00000010365, D00000010366, D00000010367, D00000010368, D00000010369, D00000010370, D00000010371, D00000010372, D00000010373, D00000010374, D00000010375, D00000010376, D00000010377, D00000010378, D00000010379, D00000010380, D00000010381, D00000010382, D00000010383, D00000010384, D00000010385, D00000010386, D00000010387, D00000010388, D00000010390, D00000010391, D00000010392, D00000010393, D00000010395, D00000010396, D00000010397, D00000010398, D00000010399, D00000010409, D00000010410, D00000010414, D00000010415, D00000010416, D00000010418, D00000010421, D00000010422, D00000010424, D00000010425, D00000010426, D00000010428, D00000010429, D00000010430, D00000010431, D00000010432, D00000010433, D00000010434, D00000010435, D00000010437, D00000010439, D00000010441, D00000010442, D00000010443, D00000010444, D00000010445, D00000010446, D00000010447, D00000010448, D00000010449, D00000010450, D00000010451, D00000010452, D00000010453, D00000010454, D00000010455, D00000010457, D00000010458, D00000010459, D00000010460, D00000010461, D00000010462, D00000010463, D00000010464, D00000010465, D00000010466, D00000010467, D00000010468, D00000010469, D00000010470, D00000010471, D00000010472, D00000010473, D00000010474, D00000010475, D00000010477, D00000010478, D00000010479, D00000010480, D00000010482, D00000010483, D00000010484, D00000010485, D00000010486, D00000010487, D00000010488, D00000010489, D00000010490, D00000010491, D00000010492, D00000010493, D00000010494, D00000010495, D00000010499, D00000010500, D00000010501, D00000010502, D00000010503, D00000010504, D00000010506, D00000010507, D00000010508, D00000010509, D00000010510, D00000010511, D00000010512, D00000010513, D00000010514, D00000010515, D00000010516, D00000010517, D00000010518, D00000010519, D00000010520, D00000010521, D00000010522, D00000010523, D00000010524, D00000010525, D00000010526, D00000010527, D00000010528, D00000010529, D00000010530, D00000010531, D00000010532, D00000010533, D00000010534, D00000010535, D00000010536, D00000010537, D00000010538, D00000010540, D00000010541, D00000010542, D00000010543, D00000010544, D00000010546, D00000010547, D00000010548, D00000010549, D00000010550, D00000010551, D00000010552, D00000010553, D00000010555, D00000010556, D00000010557, D00000010558, D00000010559, D00000010560, D00000010561, D00000010562, D00000010563, D00000010564, D00000010565, D00000010566, D00000010567, D00000010568, D00000010569, D00000010570, D00000010571, D00000010572, D00000010573, D00000010574, D00000010575, D00000010576, D00000010577, D00000010578, D00000010579, D00000010580, D00000010581, D00000010582, D00000010583, D00000010584, D00000010585, D00000010586, D00000010587, D00000010588, D00000010590, D00000010591, D00000010592, D00000010593, D00000010596, D00000010597, D00000010598, D00000010599, D00000010600, D00000010601, D00000010602, D00000010603, D00000010605, D00000010606, D00000010607, D00000010611, D00000010612, D00000010615, D00000010616, D00000010622, D00000010627, D00000010630, D00000010631, D00000010632, D00000010634, D00000010640, D00000010641, D00000010647, D00000010653, D00000010655, D00000010657, D00000010661, D00000010670, D00000010671, D00000010678, D00000010685, D00000010687, D00000010689, D00000010691, D00000010693, D00000010695, D00000010696, D00000010697, D00000010698, D00000010700, D00000010702, D00000010703, D00000010704, D00000010705, D00000010706, D00000010707, D00000010709, D00000010710, D00000010711, D00000010712, D00000010715, D00000010716, D00000010718, D00000010720, D00000010721, D00000010724, D00000010732, D00000010739, D00000010756, D00000010761, D00000010762, D00000010766, D00000010776, D00000010778, D00000010782, D00000010783, D00000010788, D00000010795, D00000010797, D00000010804, D00000010807, D00000010821, D00000010866, D00000010883, D00000010885, D00000010888, D00000010889, D00000010890, D00000010895, D00000010898, D00000010902, D00000010903, D00000010904, D00000010905, D00000010907, D00000010908, D00000010909, D00000010911, D00000010912, D00000010920, D00000010930, D00000010934, D00000010935, D00000010936, D00000010937, D00000010938, D00000010939, D00000010940, D00000010943, D00000010944, D00000010977, D00000010993, D00000011033, D00000011053, D00000011062, D00000011063, D00000011068, D00000011069, D00000011073, D00000011075, D00000011077, D00000011078, D00000011079, D00000011080, D00000011081, D00000011082, D00000011083, D00000011084, D00000011085, D00000011086, D00000011087, D00000011088, D00000011089, D00000011090, D00000011091, D00000011092, D00000011093, D00000011094, D00000011095, D00000011096, D00000011097, D00000011098, D00000011099, D00000011100, D00000011101, D00000011102, D00000011103, D00000011104, D00000011105, D00000011106, D00000011107, D00000011108, D00000011109, D00000011110, D00000011111, D00000011112, D00000011115, D00000011116, D00000011117, D00000011118, D00000011119, D00000011120, D00000011122, D00000011123, D00000011124, D00000011126, D00000011128, D00000011129, D00000011135, D00000011136, D00000011137, D00000011140, D00000011141, D00000011142, D00000011143, D00000011144, D00000011145, D00000011146, D00000011147, D00000011148, D00000011149, D00000011150, D00000011151, D00000011152, D00000011153, D00000011154, D00000011155, D00000011156, D00000011157, D00000011158, D00000011159, D00000011160, D00000011161, D00000011162, D00000011163, D00000011164, D00000011165, D00000011166, D00000011167, D00000011168, D00000011169, D00000011170, D00000011171, D00000011172, D00000011173, D00000011174, D00000011175, D00000011176, D00000011177, D00000011178, D00000011179, D00000011180, D00000011182, D00000011183, D00000011184, D00000011185, D00000011188, D00000011189, D00000011190, D00000011191, D00000011192, D000
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1317-2025
Related Recalls
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).