Class II Recall

Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-

Summary

The FDA issued a Class II for Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A by ZOLL Medical Corporation. Reason: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity)..

Details

Source

Device Recall

External ID

Z-1319-2025

Action Date

2025-03-19

Status

Ongoing

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.

Lot/Code Info: 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, D00000107378, D00000107395, D00000107405, D00000107502, D00000107507, D00000107537, D00000107565, D00000107711, D00000107713, D00000107720, D00000119052, D00000120527, D00000120550, D00000121435, D00000121441, D00000121442, D00000121455, D00000121456, D00000121457, D00000121458, D00000121459, D00000121461, D00000121462, D00000121464, D00000121465, D00000121469, D00000121470, D00000121472, D00000121476, D00000121477, D00000121482, D00000121506, D00000121527, D00000121528, D00000122755, D00000122789, D00000122794, D00000122798, D00000122806, D00000122808, D00000122813, D00000122817, D00000122845, D00000122847, D00000134901, D00000136856, D00000136864, D00000136951, D00000136957, D00000136966, D00000144818, D00000144829, D00000144830, D00000144838, D00000144848, D00000149066, D00000149085, D00000149113, D00000149120, D00000149695, D00000149701, D00000152050, D00000160405, D00000160423, D00000160496, D00000160502, D00000172568, D00000175676, D00000175713, D00000175748, D00000175769, D00000178019, D00000178021, D00000178026, D00000178029, D00000178030, D00000183047, D00000183082, D00000183146, D00000183662, D00000183746, D00000183758, D00000183759, D00000183761, D00000183775, D00000183796, D00000196083, D00000196115, D00000201889, D00000203954, D00000212126, D00000212130, D00000223042, D00000248279, D00000248281, D00000248287, D00000248288, D00000248295, D00000248296, D00000248298, D00000248316, D00000269007, D00000269308, D00000269415, D00000269625, D00000269654, D00000269743, D00000269816, D00000269852, D00000269854, D00000269855, D00000269856, D00000269858, D00000269859, D00000269864, D00000269865, D00000269867, D00000269868, D00000269869, D00000269870, D00000269871, D00000269873, D00000269875, D00000269881, D00000269882, D00000269884, D00000269887, D00000269889, D00000269890, D00000269891, D00000269893, D00000269894, D00000269896, D00000269898, D00000269900, D00000269901, D00000269902, D00000269903, D00000269904, D00000269905, D00000269906, D00000269907, D00000269910, D00000269920, D00000269926, D00000269928, D00000269931, D00000269932, D00000269933, D00000269934, D00000269935, D00000269936, D00000269937, D00000269938, D00000269939, D00000269940, D00000269941, D00000269942, D00000269943, D00000269944, D00000269946, D00000269947, D00000269949, D00000269950, D00000269951, D00000269952, D00000269953, D00000269954, D00000269955, D00000269956, D00000269957, D00000269958, D00000269959, D00000269960, D00000269961, D00000269962, D00000269963, D00000269964, D00000269965, D00000269966, D00000269967, D00000269968, D00000269969, D00000269970, D00000269971, D00000269972, D00000269973, D00000269974, D00000269975, D00000269976, D00000269977, D00000269978, D00000269979, D00000269980, D00000269981, D00000269982, D00000269983, D00000269984, D00000269985, D00000269986, D00000269987, D00000269988, D00000269989, D00000269990, D00000269991, D00000269992, D00000269993, D00000269994, D00000269995, D00000269996, D00000269997, D00000269998, D00000269999, 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,

Quantity Affected: 960 units

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).

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2025-02-13

Company

ZOLL Medical Corporation

Chelmsford, MA

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 159 device recalls issued in the same week, part of 403 device-related FDA actions this month.

ZOLL Medical Corporation has 11 FDA actions in our database, including 10 recalls and 1 clearance.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ZOLL Medical Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does ZOLL Medical Corporation have FDA actions?

ZOLL Medical Corporation has 11 FDA actions in our database, including 10 recalls and 1 device clearance.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1319-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

Want to know the moment something like this happens?

Get alerts for device

Related Actions

MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200

Covidien LP · 2023-08-23

Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO

MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15

VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri

Boston Scientific Corporation · 2024-09-25

EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo

Enchroma Inc · 2024-11-27

Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;

Adept Medical Ltd · 2025-01-29