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Brand Name: ZOLL recallZ-1319-2025 · ZOLL Medical Corporation · initiated Feb 13, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from ZOLL Medical Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Unknown/Undetermined by firm

What the company is doing

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.

Recall details

Recall number
Z-1319-2025
Status
Open, Classified
Initiated by the company
Feb 13, 2025
Posted by the FDA
Mar 12, 2025
Recalling firm
ZOLL Medical Corporation
Quantity
960 units
Product code
MKJ
FDA submissions
P160033
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 description

Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-08C, (5) G5A-10C, (6) G5A-13C, (7) G5A-15C, (8) G5A-22C, (9) G5A-41C, (10) G5A-85C, (11) G5A-90C (12) G5A-80-L; 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 (models, lots, serial numbers)

Show the full code information (14k characters)

Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-08C, (5) G5A-10C, (6) G5A-13C, (7) G5A-15C, (8) G5A-22C, (9) G5A-41C, (10) G5A-85C, (11) G5A-90C (12) G5A-80-L; UDI-DI: (1) 00812394021161, (2) no UDI, (3) no UDI, (4) no UDI, (5) no UDI, (6) no UDI, (7) no UDI, (8) no UDI, (9) no UDI, (10) 00812394021208 (11) no UDI, (12) 00812394021215; Serial Numbers: (1) D00000066618, D00000066630, D00000066659, D00000066773, D00000067078, D00000067079, D00000067081, D00000067082, D00000067086, D00000067088, D00000067092, D00000067094, D00000067097, D00000067099, D00000067100, D00000067103, D00000067108, D00000067109, D00000067114, D00000067117, D00000067129, D00000067133, D00000067135, D00000067136, D00000067138, D00000067139, D00000067143, D00000067145, D00000067171, D00000067172, D00000067174, D00000067178, D00000067180, D00000067183, D00000067184, D00000067186, D00000067192, D00000067195, D00000067197, D00000067199, D00000067204, D00000067209, D00000067212, D00000067217, D00000067219, D00000067224, D00000067233, D00000067235, D00000067267, D00000067303, D00000067384, D00000067456, D00000067577, D00000067601, D00000067614, D00000067638, D00000067640, D00000067644, D00000067646, D00000067651, D00000067652, D00000067653, D00000067654, D00000067655, D00000067658, D00000067660, D00000067664, D00000067665, D00000067666, D00000067667, D00000067668, D00000067669, D00000067696, D00000067697, D00000067714, D00000067748, D00000067755, D00000067756, D00000067758, D00000067762, D00000067763, D00000067764, D00000067765, D00000067769, D00000067770, D00000067771, D00000067772, D00000067773, D00000067777, D00000067785, D00000075495, D00000075574, D00000085953, D00000085968, D00000089895, D00000089936, D00000090085, D00000094487, D00000094513, D00000094806, D00000097094, D00000104028, D00000104049, D00000104062, D00000104086, D00000104174, D00000105727, D00000105728, D00000107074, D00000107083, D00000107094, D00000107112, D00000107116, D00000107180, D00000107267, 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D00000270000, D00000270001, D00000270002, D00000270003, D00000270004, D00000270005, D00000270006, D00000270007, D00000270008, D00000270009, D00000270010, D00000270011, D00000270012, D00000270013, D00000270014, D00000270015, D00000270016, D00000270017, D00000270018, D00000270019, D00000270020, D00000270021, D00000270022, D00000270023, D00000270024, D00000270025, D00000270026, D00000270028, D00000270029, D00000270031, D00000270032, D00000270033, D00000270034, D00000270035, D00000270036, D00000270037, D00000270038, D00000270040, D00000270041, D00000270042, D00000270043, D00000270044, D00000270045, D00000270046, D00000270047, D00000270048, D00000270049, D00000270050, D00000270051, D00000270052, D00000270053, D00000270054, D00000270055, D00000270056, D00000270058, D00000270059, D00000270060, D00000270061, D00000270062, D00000270063, D00000270064, D00000270065, D00000270067, D00000270068, D00000270069, D00000270070, D00000270071, D00000270072, D00000270073, D00000270074, D00000270075, D00000270076, D00000270077, D00000270078, D00000270079, D00000270080, D00000270081, D00000270082, D00000270084, D00000270085, D00000270086, D00000270088, D00000270089, D00000270090, D00000270091, D00000270092, D00000270093, D00000270094, D00000270095, D00000270096, D00000270097, D00000270098, D00000270099, D00000270100, D00000270101, D00000270102, D00000270103, D00000270104, D00000270105, D00000270106, D00000270107, D00000270108, D00000270109, D00000270110, D00000270112, D00000270113, D00000270114, D00000270115, D00000270116, D00000270117, D00000270118, D00000270119, D00000270120, D00000270121, D00000270122, D00000270123, D00000270124, D00000270125, D00000270126, D00000270127, D00000270128, D00000270129, D00000270130, D00000270131, D00000270132, D00000270134, D00000270135, D00000270136, D00000270137, D00000270138, D00000270139, D00000270144, D00000270145, D00000270146, D00000270147, D00000270148, D00000270149, D00000270151, D00000270152, D00000270153, D00000270154, D00000270155, D00000270156, D00000270157, D00000270158, D00000270159, D00000270160, D00000270161, D00000270162, D00000270163, D00000270164, D00000270165, D00000270166, D00000270167, D00000270168, D00000270169, D00000270170, D00000270171, D00000270172, D00000270173, D00000270174, D00000270175, D00000270176, D00000270177, D00000270178, D00000270179, D00000270180, D00000270181, D00000270182, D00000270183, D00000270184, D00000270185, D00000270186, D00000270187, D00000270188, D00000270191, D00000270192, D00000270196, D00000270198, D00000270199, D00000270200, D00000270202, D00000270203, D00000270204, D00000270205, D00000270206, D00000270208, D00000270209, D00000270210, D00000270212, D00000270213, D00000270214, D00000270218, D00000270221, D00000270223, D00000270224, D00000270226, D00000270241, D00000274470, D00000274521, D00000274567, D00000274593, D00000274644, D00000274681, D00000274787, D00000274823, D00000274884, D00000274892, D00000274899, D00000274965, D00000274976, D00000275091, D00000275094, D00000275097, D00000275124, D00000275152, D00000275153, D00000275154, D00000275155, D00000275156, D00000275158, D00000275159, D00000275160, D00000275161, D00000275169, D00000275170, D00000275171, D00000275183, D00000275185, D00000275186, D00000275189, D00000275190, D00000275191, D00000275195, D00000275198, D00000275200, D00000275201, D00000275202, D00000275203, D00000275205, D00000275206, D00000275207, D00000275208, D00000275212, D00000275215, D00000275219, D00000275220, D00000275221, D00000275222, D00000275223, D00000275230, D00000275231, D00000275232, D00000275233, D00000275234, D00000275235, D00000275237, D00000275241, D00000275242, D00000275246, D00000275248, D00000275249, D00000275250, D00000275251, D00000275252, D00000275253, D00000275254, D00000275255, D00000275256, D00000275257, D00000275258, D00000275261, D00000275262, D00000275263, D00000275264, D00000275271, D00000275274, D00000275275, D00000275277, D00000275278, D00000275281, D00000275283, D00000275285, D00000275286, D00000275287, D00000275288, D00000275289, D00000275290, D00000275291, D00000275292, D00000275293, D00000275294, D00000275295, D00000275296, D00000275297, D00000275298, D00000275299, D00000275300, D00000275301, D00000275303, D00000275304, D00000275308, D00000275310, D00000275317, D00000275319, D00000275321, D00000275322, D00000275323, D00000275325, D00000275327, D00000275328, D00000275331, D00000275332, D00000275333, D00000275335, D00000275337, D00000275339, D00000275340, D00000275341, D00000275343, D00000275344, D00000275348, D00000275349, D00000275354, D00000275358, D00000275361, D00000275362, D00000275369, D00000275371, D00000275373, D00000275376, D00000275377, D00000275378, D00000275379, D00000275380, D00000275390, D00000275391, D00000275394, D00000275396, D00000275398, D00000275399, D00000275400, D00000275401, D00000275402, D00000275403, D00000275408, D00000275413, D00000275414, D00000275420, D00000275421, D00000275428, D00000275429, D00000275430, D00000275431, D00000275433, D00000275434, D00000275435, D00000275439, D00000275440, D00000275441, D00000275444, D00000275445, D00000275446, D00000275450, D00000275452, D00000275457, D00000275458, D00000275459, D00000275460, D00000275461, D00000275462, D00000275464, D00000275465, D00000275466, D00000275467, D00000275468, D00000275469, D00000275472, D00000275473, D00000275474, D00000275475, D00000275476, D00000275477, D00000275478, D00000275481, D00000275482, D00000275484, D00000275485, D00000275486, D00000275487, D00000275489, D00000275492, D00000275493, D00000275494, D00000275496, D00000275497, D00000275501, D00000275502, D00000275503, D00000275504, D00000275505, D00000275506, D00000275507, D00000275508, D00000275511, D00000275512, D00000275513, D00000275514, D00000275515, D00000275517, D00000275518, D00000275519, D00000275520, D00000275522, D00000275524, D00000275527, D00000275529, D00000275532, D00000275535, D00000275536, D00000275537, D00000275539, D00000275540, D00000275541, D00000275542, D00000275544, D00000275545, D00000275546, D00000275562, D00000275564, D00000275565, D00000275566, D00000275567, D00000275569, D00000275570, D00000275574, D00000275578, D00000275579, D00000275581, D00000275582, D00000275583, D00000275584, D00000275587, D00000275588, D00000275590, D00000275591, D00000275592, D00000275593, D00000275594, D00000275597, D00000275598, D00000275599, D00000275600, D00000275601, D00000275603, D00000275604, D00000275605, D00000275606, D00000275607, D00000275608, D00000275609, D00000275610, D00000275611, D00000275635, D00000275637, D00000275638, D00000275643, D00000275649, D00000275650, D00000275651, D00000275652, D00000275653, D00000275655, D00000275658, D00000275659, D00000275660, D00000275661, D00000275685, D00000275686, D00000275687, D00000275688, D00000275689, D00000275690, D00000275692, D00000275693, D00000275694, D00000275697, D00000275714, D00000275720, D00000275724, D00000275733, D00000275735, (2) D00000005212, D00000005227, D00000005232, D00000005239, D00000005276, D00000158547, D00000158549, D00000158620, D00000158646, D00000158656, D00000158661, D00000158678, D00000158682, D00000158685, D00000158712, D00000158716, D00000158717, D00000158723, (3) D00000169508, (4) D00000112016, D00000120996, D00000120997, D00000158450, D00000158480, D00000158489, D00000158555, D00000158562, D00000158681, D00000158700, D00000158839, D00000158841, D00000158845, D00000158846, D00000158848, D00000158849, D00000158852, D00000158863, D00000158865, D00000158866, D00000158874, D00000158887, D00000158890, D00000158897, D00000158900, D00000158903, D00000158905, D00000158907, D00000158912, D00000158918, D00000158934, D00000158937, D00000158938, D00000158942, D00000184320, M00000008557, (5) D00000171663, D00000171665, D00000171666, D00000171788, D00000171789, (6) D00000158867, D00000158877, D00000158880, D00000158889, (7) D00000158524, D00000158563, D00000158584, D00000158598, D00000158613, D00000158614, D00000178683, (8) D00000158894, D00000158923, D00000158975, D00000169406, D00000169490, D00000169495, D00000169507, (9) D00000242577, D00000242588, D00000242589, D00000242590, D00000242591, D00000242592, D00000242593, D00000242594, D00000242595, D00000242596, D00000242597, D00000242598, D00000242599, D00000242600, D00000242601, D00000242602, D00000242604, D00000242605, D00000242606, D00000242608, D00000242610, D00000242611, D00000242612, D00000242613, D00000242614, D00000242615, D00000242616, (10) D00000158789, D00000158855, D00000158862, D00000158872, D00000158879, D00000158899, D00000158935, D00000158945, D00000158947, D00000158949, D00000158950, D00000158953, D00000158954, D00000158960, D00000158965, D00000158993, D00000158998, D00000158999, D00000159000, (11) D00000200471, D00000232580, (12) D00000003926, D00000004352, D00000013842, D00000017341, D00000028210, D00000046191, D00000046197, D00000046413, D00000077713, D00000110118, D00000110126, D00000110131, D00000129470, M00000014257.

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 96198).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page