Exact FDA event identifier

Event 96198

8 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: February 13, 2025
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: ZOLL Medical Corporation

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

8 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 8

Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A-03A, (5) G5A-19A, (6) G5A-80A, (7) 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.

Z-1316-2025

Recall number: Z-1316-2025
Initiated: February 13, 2025
Classification: Class II
Status: Ongoing
Recalling firm: ZOLL Medical Corporation
Quantity: 2268 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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).

Code information

Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A-03A, (5) G5A-19A, (6) G5A-80A, (7) G5A-80A-TSO; UDI-DI: (1) no UDI, (2) 00812394021154, (3) no UDI, (4) no UDI, (5) 00812394022243, (6) 00812394021192, (7) 00812394021390; Serial Numbers: (1) D00000177884, D00000177917, D00000177931, D00000177956, D00000178271, D00000178311, D00000178395, D00000178542, M00000002041, M00000008225, M00000008290, M00000008336, (2) D00000003482, D00000003546, D00000003557, D00000003600, D00000003625, D00000003783, D00000003978, D00000003983, D00000003985, D00000004036, D00000004037, D00000004040, D00000004043, D00000004089, D00000004098, D00000004100, D00000004105, D00000004107, D00000004109, D00000004111, D00000004116, D00000004118, D00000004119, D00000004120, D00000004123, D00000004129, D00000004131, D00000004132, D00000004133, D00000004138, D00000004140, D00000004141, D00000004142, D00000004143, D00000004145, D00000004146, D00000004147, D00000004148, D00000004150, D00000004155, 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D00000102118, D00000102771, D00000102818, D00000102830, D00000102839, D00000102842, D00000103506, D00000103510, D00000103515, D00000103573, D00000103578, D00000104113, D00000104141, D00000104143, D00000104155, D00000104221, D00000104391, D00000104487, D00000104509, D00000104561, D00000104563, D00000104571, D00000104574, D00000104576, D00000104586, D00000104587, D00000106128, D00000106403, D00000106408, D00000106420, D00000106442, D00000106451, D00000106452, D00000106473, D00000106497, D00000106499, D00000106503, D00000106505, D00000106508, D00000106992, D00000107059, D00000107081, D00000107096, D00000107099, D00000109821, D00000109827, D00000109828, D00000109857, D00000109860, D00000109861, D00000109886, D00000109888, D00000109889, D00000109891, D00000112162, D00000112172, D00000112180, D00000112189, D00000112193, D00000117371, D00000117440, D00000118125, D00000118133, D00000118136, D00000118138, D00000118139, D00000118140, D00000118151, D00000118154, D00000118155, D00000118157, D00000118158, D00000118161, D00000118163, D00000118170, D00000118325, D00000118408, D00000119564, D00000119643, D00000119645, D00000119730, D00000119741, D00000119756, D00000119759, D00000119787, D00000119788, D00000119792, D00000119796, D00000120317, D00000120360, D00000121388, D00000121436, D00000121466, D00000121468, D00000121473, D00000121478, D00000121483, D00000121544, D00000121553, D00000121561, D00000121562, D00000121564, D00000121566, D00000122677, D00000122679, D00000122726, D00000122727, D00000122749, D00000122753, D00000122761, D00000122768, D00000122775, D00000122782, D00000126484, D00000126498, D00000126589, D00000127128, D00000127133, D00000127151, D00000127153, D00000127165, D00000127183, D00000127194, D00000130143, D00000130189, D00000130195, D00000130206, D00000130224, D00000130227, D00000132431, D00000132433, D00000132434, D00000132435, D00000132437, D00000135640, D00000135711, D00000135713, D00000135715, D00000135716, D00000136551, D00000136574, D00000136575, D00000136587, D00000136588, D00000136602, D00000136606, D00000136614, D00000136615, D00000136636, D00000136642, D00000136650, D00000136662, D00000137249, D00000137281, D00000137325, D00000137371, D00000137374, D00000140722, D00000140812, D00000140822, D00000140826, D00000140838, D00000140874, D00000140876, D00000140944, D00000144477, D00000144499, D00000144517, D00000144525, D00000144530, D00000144535, D00000144553, D00000146191, D00000146193, D00000146196, D00000146198, D00000146247, D00000146251, D00000146622, D00000146632, D00000146644, D00000146645, D00000146655, D00000146661, D00000146669, D00000146683, D00000146685, D00000146696, D00000150374, D00000150392, D00000150409, D00000150410, D00000150427, D00000150430, D00000150435, D00000150436, D00000150440, D00000150442, D00000150444, D00000150452, D00000150457, D00000150461, D00000150462, D00000150464, D00000150467, D00000150496, D00000150499, D00000150505, D00000150508, D00000150517, D00000150519, D00000151298, D00000151299, D00000151308, D00000151309, D00000151310, D00000151311, D00000151315, D00000151316, D00000151317, D00000151318, D00000151321, D00000151322, D00000151323, D00000151324, D00000151325, D00000151327, D00000151331, D00000151358, D00000151360, D00000151365, D00000151366, D00000151369, D00000151370, D00000151384, D00000151385, D00000151386, D00000151388, D00000151628, D00000151631, D00000151673, D00000152424, D00000152425, D00000152427, D00000152431, D00000152474, D00000152476, D00000152480, D00000154025, D00000155104, D00000155110, D00000155118, D00000155127, D00000155140, D00000155144, D00000155154, D00000155156, D00000155179, D00000155183, D00000155205, D00000155215, D00000155224, D00000155228, D00000155230, D00000155233, D00000155236, D00000155237, D00000155239, D00000155247, D00000155250, D00000155292, D00000157281, D00000157316, D00000157433, D00000157435, D00000157437, D00000158883, D00000158952, D00000158955, D00000158963, D00000158981, D00000158994, D00000159012, D00000159267, D00000159280, D00000159287, D00000159335, D00000159348, D00000159871, D00000160277, D00000160279, D00000160310, D00000160312, D00000160314, D00000160321, D00000160323, D00000160326, D00000160328, D00000160330, D00000160333, D00000160336, D00000160339, D00000160340, D00000160341, D00000160342, D00000160343, D00000160344, D00000160346, D00000160347, D00000160351, D00000160354, D00000160357, D00000160359, D00000160362, D00000160365, D00000160366, D00000160368, D00000160369, D00000160371, D00000160372, D00000160373, D00000160374, D00000160375, D00000160376, D00000160377, D00000160379, D00000160382, D00000160383, D00000160384, D00000160385, D00000160386, D00000160387, D00000160388, D00000160390, D00000160391, D00000160392, D00000160393, D00000160394, D00000160396, D00000160398, D00000160400, D00000160408, D00000161910, D00000162538, D00000162540, D00000162552, D00000162593, D00000162613, D00000163743, D00000164161, D00000164186, D00000164187, D00000164191, D00000164194, D00000164203, 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D00000167056, D00000169463, D00000169485, D00000169570, D00000169571, D00000169593, D00000169597, D00000169599, D00000169611, D00000169616, D00000169637, D00000173112, D00000173153, D00000173156, D00000173160, D00000173162, D00000173164, D00000173165, D00000173167, D00000173168, D00000173171, D00000173172, D00000173176, D00000173179, D00000173182, D00000173192, D00000173196, D00000173199, D00000173200, D00000173221, D00000173224, D00000173225, D00000173226, D00000173227, D00000173229, D00000173233, D00000173234, D00000173235, D00000173236, D00000173237, D00000173239, D00000173240, D00000173246, D00000173248, D00000173252, D00000173255, D00000173258, D00000173265, D00000173266, D00000173843, D00000173893, D00000173906, D00000173949, D00000175374, D00000175387, D00000177037, D00000177038, D00000178032, D00000178040, D00000178050, D00000178062, D00000178067, D00000178069, D00000178070, D00000178071, D00000178076, D00000178080, D00000178091, D00000178093, D00000178100, D00000178101, D00000178104, D00000178108, D00000178116, D00000178118, D00000178128, D00000178131, D00000178132, D00000178136, D00000184822, D00000184845, D00000184889, D00000185922, D00000186276, D00000191653, D00000191661, D00000191727, D00000191729, D00000191732, D00000191736, D00000191747, D00000191766, D00000191771, D00000193156, D00000193161, D00000193163, D00000193164, D00000193165, D00000196513, D00000196516, D00000204614, D00000204647, D00000204650, D00000211731, D00000211742, D00000211770, D00000211771, D00000211775, D00000217516, D00000217539, D00000217544, D00000217557, D00000217570, D00000217572, D00000217581, D00000217602, D00000217611, D00000217612, D00000217621, D00000217651, D00000223579, D00000240888, D00000240890, D00000251653, D00000251670, D00000251672, D00000251756, D00000251768, D00000251780, D00000251783, D00000251787, D00000251790, D00000251791, D00000270189, D00000270190, D00000270225, D00000270228, D00000270230, D00000270231, D00000270233, D00000270235, D00000270243, D00000270245, D00000270252, D00000270271, D00000270272, D00000270276, M00000014302, M00000014596, M00000014610, M00000014631, M00000014632, M00000014636, M00000014638, M00000014652, M00000014667, M00000014740, M00000014830, M00000014844, M00000014886, M00000014893, M00000014899, M00000014927, M00000014963, M00000014965, M00000014966, M00000014967, M00000014968, M00000014970, M00000014973, M00000014975, M00000014976, M00000014983, M00000014991, M00000015008, M00000015013, M00000015015, M00000015017, M00000015018, M00000015020, M00000015021, M00000015023, M00000015028, M00000015030, M00000015031, M00000015032, M00000015034, M00000015037, M00000015046, M00000015049, M00000015261, M00000015346, M00000015388, M00000015430, M00000015436, M00000015469, M00000015483, M00000015515, M00000015521, M00000015522, M00000015552, M00000015570, M00000015679, M00000015691, (3) D00000237326, M00000009615, (4) D00000183040, D00000183084, (5) D00000243580, D00000243582, D00000243594, D00000243601, D00000243602, D00000243604, D00000243605, D00000243606, D00000243608, D00000243610, D00000243617, D00000243629, D00000243637, D00000243640, D00000243641, D00000243644, D00000243645, D00000243647, D00000243650, D00000243661,

Distribution pattern

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.

device · product 2 of 8

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.

Z-1317-2025

Recall number: Z-1317-2025
Initiated: February 13, 2025
Classification: Class II
Status: Ongoing
Recalling firm: ZOLL Medical Corporation
Quantity: 56,981 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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).

Code information

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, D00000004244, D00000004245, D00000004250, D00000004251, D00000004252, D00000004256, D00000004260, D00000004264, D00000004265, D00000004275, D00000004307, D00000004315, D00000004377, D00000004380, D00000004382, D00000004383, D00000004385, D00000004386, D00000004387, D00000004391, D00000004392, D00000004395, D00000004396, D00000004397, D00000004398, D00000004399, D00000004401, D00000004406, D00000004409, D00000004414, D00000004415, D00000004416, D00000004417, D00000004418, D00000004420, D00000004422, D00000004426, D00000004428, D00000004429, D00000004433, D00000004442, D00000004444, D00000004446, D00000004447, D00000004449, D00000004450, D00000004452, D00000004453, D00000004459, D00000004461, D00000004462, D00000004463, D00000004465, D00000004471, D00000004472, D00000004474, D00000004476, D00000004477, D00000004485, D00000004486, D00000004487, D00000004491, D00000004494, D00000004495, D00000004498, D00000004499, D00000004500, D00000004503, D00000004504, D00000004505, D00000004506, D00000004507, D00000004510, D00000004511, D00000004512, D00000004513, D00000004514, D00000004522, D00000004526, D00000004527, D00000004529, D00000004531, D00000004534, D00000004535, D00000004538, D00000004540, D00000004542, D00000004543, D00000004546, D00000004551, D00000004575, D00000004579, D00000004585, D00000004589, D00000004591, D00000004594, D00000004595, D00000004596, D00000004597, D00000004598, D00000004601, D00000004602, D00000004604, D00000004605, D00000004607, D00000004608, D00000004610, D00000004614, D00000004676, D00000004677, D00000004685, D00000004689, D00000004695, D00000004704, D00000004705, D00000004706, D00000004707, D00000004709, D00000004710, D00000004711, D00000004712, D00000004720, D00000004722, D00000004724, D00000004748, D00000004751, D00000004753, D00000004830, D00000005146, D00000005147, D00000005148, D00000005153, D00000005154, D00000005155, D00000005160, D00000005162, D00000005170, D00000005176, D00000005179, D00000005262, D00000005263, D00000005264, D00000005265, D00000005266, D00000005268, D00000005269, D00000005270, D00000005271, D00000005283, D00000005284, D00000005285, D00000005286, D00000005287, D00000005288, D00000005289, D00000005290, D00000005291, D00000005292, D00000005293, D00000005294, D00000005295, D00000005296, D00000005297, D00000005298, D00000005299, D00000005300, D00000005301, D00000005302, D00000005303, D00000005304, D00000005305, D00000005306, D00000005307, D00000005308, D00000005309, D00000005310, D00000005311, D00000005312, D00000005313, D00000005314, D00000005315, D00000005316, D00000005318, D00000005320, D00000005321, D00000005322, D00000005327, D00000005357, D00000006043, D00000006044, D00000006045, D00000006046, D00000006047, D00000006048, D00000006049, D00000006050, D00000006051, D00000006052, D00000006053, 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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, 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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

Distribution pattern

device · product 3 of 8

Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80C, (2) G5A-80C-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.

Z-1318-2025

Recall number: Z-1318-2025
Initiated: February 13, 2025
Classification: Class II
Status: Ongoing
Recalling firm: ZOLL Medical Corporation
Quantity: 63,607 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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).

Code information

Model/Catalog Number: (1) G5A-80C, (2) G5A-80C-TSO; UDI-DI: (1) 00812394021208, (2) 00812394021406; Serial Numbers: (1) D00000022708, D00000033165, D00000033168, D00000033171, D00000033174, D00000033185, D00000033187, D00000033189, D00000033191, D00000033208, D00000033209, D00000033211, D00000033213, D00000033214, D00000033216, D00000033217, D00000033219, D00000033220, D00000033221, D00000033222, D00000033230, D00000035201, D00000035208, D00000035246, D00000035445, D00000035512, D00000035517, D00000035521, D00000035523, D00000035524, D00000035525, D00000035528, D00000035530, D00000035532, D00000035534, D00000035536, D00000035538, D00000035539, D00000035542, D00000035544, D00000035546, D00000035548, D00000035549, D00000035554, D00000035558, D00000035560, D00000035562, D00000035584, D00000035585, D00000035588, D00000035589, D00000035591, D00000035594, D00000035595, D00000035599, D00000035601, D00000035603, D00000035605, D00000035607, D00000035610, D00000035614, D00000035825, 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D00000044158, D00000044160, D00000044162, D00000044164, D00000044165, D00000044167, D00000044169, D00000044171, D00000044173, D00000044175, D00000044176, D00000044177, D00000044178, D00000044183, D00000044185, D00000044187, D00000044190, D00000044191, D00000044192, D00000044193, D00000044194, D00000044195, D00000044197, D00000044199, D00000044201, D00000044213, D00000044214, D00000044215, D00000044216, D00000044235, D00000044238, D00000044239, D00000044241, D00000044247, D00000044248, D00000044249, D00000044250, D00000044251, D00000044252, D00000044253, D00000044254, D00000044255, D00000044256, D00000044272, D00000044276, D00000044286, D00000044287, D00000044306, D00000044307, D00000044324, D00000044326, D00000044328, D00000044331, D00000044332, D00000044336, D00000044348, D00000044351, D00000044352, D00000044651, D00000044791, D00000044802, D00000044813, D00000044913, D00000044935, D00000045020, D00000045056, D00000045085, D00000045089, D00000045091, D00000045117, D00000045196, 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Distribution pattern

device · product 4 of 8

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.

Z-1319-2025

Recall number: Z-1319-2025
Initiated: February 13, 2025
Classification: Class II
Status: Ongoing
Recalling firm: ZOLL Medical Corporation
Quantity: 960 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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).

Code information

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, 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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,

Distribution pattern

device · product 5 of 8

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 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.

Z-1320-2025

Recall number: Z-1320-2025
Initiated: February 13, 2025
Classification: Class II
Status: Ongoing
Recalling firm: ZOLL Medical Corporation
Quantity: 73 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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).

Code information

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;

Distribution pattern

device · product 6 of 8

Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; 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.

Z-1321-2025

Recall number: Z-1321-2025
Initiated: February 13, 2025
Classification: Class II
Status: Ongoing
Recalling firm: ZOLL Medical Corporation
Quantity: 7,221 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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).

Code information

Model/Catalog Number: G5S-80C; UDI-DI: 00812394021284; Serial Numbers: D00000171086, D00000171087, D00000171088, D00000171089, D00000171090, D00000171092, D00000171093, D00000171094, D00000171095, D00000171096, D00000171097, D00000171098, D00000171099, D00000171100, D00000171101, D00000171102, D00000171103, D00000171105, D00000171107, D00000171109, D00000171111, D00000171113, D00000171115, D00000171117, D00000171118, D00000171121, D00000171126, D00000171133, D00000171134, D00000171136, D00000171138, D00000171140, D00000171144, D00000171147, D00000171150, D00000171154, D00000171157, D00000171159, D00000171160, D00000171164, D00000171165, D00000171166, D00000171167, D00000171168, D00000171169, D00000171170, D00000171171, D00000171172, D00000171178, D00000171179, D00000171181, D00000171183, D00000171186, D00000171188, D00000171190, D00000171601, D00000172373, D00000172376, D00000172379, D00000172381, D00000172382, D00000172383, D00000172384, D00000172385, D00000172386, D00000172391, D00000172412, D00000172413, D00000172414, D00000172416, D00000172421, D00000172422, D00000172425, D00000172426, D00000172428, D00000172430, D00000172431, D00000172432, D00000172433, D00000172434, D00000172435, D00000172436, D00000172437, D00000172438, D00000172439, D00000172444, D00000172446, D00000172448, D00000172449, D00000172455, D00000172466, D00000172473, D00000172482, D00000172483, D00000172484, D00000172486, D00000172487, D00000172488, D00000172489, D00000172493, D00000172497, D00000172503, D00000172506, D00000172563, D00000172565, D00000172571, D00000172572, D00000172583, D00000172589, D00000172592, D00000172616, D00000172742, D00000172985, D00000172991, D00000172999, D00000173001, D00000173008, D00000173019, D00000173025, D00000173043, D00000173048, D00000173050, D00000173056, D00000173057, D00000173061, D00000173062, D00000173067, D00000173068, D00000173069, D00000173070, D00000173071, D00000173074, D00000173079, D00000173091, D00000173093, D00000173094, D00000173095, D00000173096, D00000173097, D00000173099, D00000173100, D00000173102, D00000173104, D00000173107, D00000173111, D00000173114, D00000173115, D00000173116, D00000173122, D00000173125, D00000173132, D00000173133, D00000173135, D00000173137, D00000173138, D00000173145, D00000173146, D00000173147, D00000173151, D00000173152, D00000173154, D00000173155, D00000173170, D00000173218, D00000173219, D00000173220, D00000173222, D00000173231, D00000173238, D00000173244, D00000173247, D00000173321, D00000175078, D00000175082, D00000175148, D00000175165, D00000175190, D00000175192, D00000175194, D00000175196, D00000175209, D00000175211, D00000175225, D00000175229, D00000175251, D00000175253, D00000175254, D00000175268, D00000175342, D00000175750, D00000175752, D00000175755, D00000175756, D00000175758, D00000175759, D00000175765, D00000175766, D00000175767, D00000175768, D00000175770, D00000175772, D00000175773, D00000175774, D00000175775, D00000175776, D00000175780, D00000175792, D00000175809, D00000177781, D00000177794, D00000177803, D00000177805, D00000177811, D00000177812, D00000177813, D00000177814, D00000177815, D00000177817, D00000177818, D00000177823, D00000177824, D00000177826, D00000177827, D00000177831, D00000177846, D00000177848, D00000177849, D00000177850, D00000177851, D00000177852, D00000177853, D00000177854, D00000177855, D00000177856, D00000177861, D00000177862, D00000177863, D00000177865, D00000177867, D00000181120, D00000181132, D00000181153, D00000181165, D00000181179, D00000181198, D00000181203, D00000181206, D00000181212, D00000181233, D00000181250, D00000181253, D00000181267, D00000181290, D00000181294, D00000181309, D00000181310, D00000181329, D00000181334, D00000181347, D00000181352, D00000181367, D00000181372, D00000181876, D00000181881, D00000181960, D00000181964, D00000181965, D00000182004, D00000182016, D00000182017, D00000182025, D00000182037, D00000182040, D00000182193, D00000182196, D00000182198, D00000182212, D00000182243, D00000182276, 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D00000182775, D00000182776, D00000182777, D00000182778, D00000182781, D00000182786, D00000182788, D00000182789, D00000182791, D00000182792, D00000182795, D00000182796, D00000182799, D00000182804, D00000182812, D00000182813, D00000182814, D00000182817, D00000182818, D00000182827, D00000182829, D00000182831, D00000182832, D00000182833, D00000182834, D00000182835, D00000182837, D00000182838, D00000182844, D00000182846, D00000182848, D00000182849, D00000182853, D00000182855, D00000182856, D00000182858, D00000182859, D00000182860, D00000182861, D00000182862, D00000182863, D00000182864, D00000182865, D00000182868, D00000182869, D00000182874, D00000182898, D00000182901, D00000182904, D00000182905, D00000182906, D00000182907, D00000182908, D00000182910, D00000182935, D00000182944, D00000182945, D00000182954, D00000182965, D00000182996, D00000182999, D00000183031, D00000183475, D00000183479, D00000183482, D00000183505, D00000183533, D00000183534, D00000183536, D00000183559, D00000183561, D00000183564, D00000183568, D00000183572, D00000183577, D00000183578, D00000183579, D00000183626, D00000183646, D00000183669, D00000183718, D00000183735, D00000183745, D00000183750, D00000183763, D00000183764, D00000183765, D00000183768, D00000183769, D00000183770, D00000183771, D00000183772, D00000183774, D00000183776, D00000183777, D00000183778, D00000183781, D00000183787, D00000183817, D00000183974, D00000183975, D00000184000, D00000184001, D00000184018, D00000184099, D00000184110, D00000184114, D00000184118, D00000184120, D00000184127, D00000184132, D00000184668, D00000184714, D00000184745, D00000184749, D00000184778, D00000184786, D00000184794, D00000184820, D00000184833, D00000184835, D00000184839, D00000184840, D00000184842, D00000184847, D00000184849, D00000184855, D00000184867, D00000184872, D00000184873, D00000184874, D00000184875, D00000184876, D00000184877, D00000184878, D00000184881, D00000184886, D00000184890, D00000184895, D00000184898, D00000184904, D00000184907, D00000184910, D00000184912, D00000185089, D00000185126, D00000185127, D00000185131, D00000185136, D00000185149, D00000185151, D00000185152, D00000185160, D00000185163, D00000185164, D00000185165, D00000185167, D00000185169, D00000185171, D00000185172, D00000185173, D00000185175, D00000185177, D00000185178, D00000185184, D00000185185, D00000185187, D00000185188, D00000185191, D00000185192, D00000185193, D00000185194, D00000185198, D00000185199, D00000185201, D00000185202, D00000185204, D00000185206, D00000185207, D00000185209, D00000185217, D00000185220, D00000185227, D00000185231, D00000185233, D00000185237, D00000185241, D00000185246, D00000185248, D00000185252, D00000185257, D00000185261, D00000185272, D00000185289, D00000185292, D00000185300, D00000185348, D00000185361, D00000185715, D00000185882, D00000186207, D00000186295, D00000186297, D00000186298, D00000186299, D00000186322, D00000186328, D00000186331, D00000186343, D00000186357, D00000186380, D00000186383, D00000186392, D00000186396, D00000186399, D00000186401, D00000186406, D00000186412, D00000186415, D00000186428, D00000186430, D00000186431, D00000186454, D00000186461, D00000186467, D00000186482, D00000186484, D00000186498, D00000186509, D00000186510, D00000186515, D00000186519, D00000186523, D00000186526, D00000186556, D00000186618, D00000186625, D00000187501, D00000187529, D00000187541, D00000187563, D00000187581, D00000187586, D00000187668, D00000188251, D00000188254, D00000188283, D00000188289, D00000188294, D00000188295, D00000188301, D00000188303, D00000188307, D00000188308, D00000188316, D00000188317, D00000188320, D00000188321, D00000188322, D00000188323, D00000188324, D00000188325, D00000188326, D00000188327, D00000188328, D00000188329, D00000188330, D00000188331, D00000188333, D00000188334, D00000188335, D00000188336, D00000188339, D00000188340, D00000188341, D00000188342, D00000188343, D00000188346, D00000188347, D00000188348, D00000188350, D00000188353, D00000188368, D00000188369, 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D00000191703, D00000191705, D00000191706, D00000191708, D00000191710, D00000191713, D00000191717, D00000191725, D00000191726, D00000191728, D00000191730, D00000191735, D00000191737, D00000191741, D00000191744, D00000191749, D00000191752, D00000191753, D00000191755, D00000191756, D00000191757, D00000191758, D00000191759, D00000191760, D00000191762, D00000191775, D00000191776, D00000191777, D00000191778, D00000191779, D00000191781, D00000191783, D00000191786, D00000191787, D00000191788, D00000191790, D00000191791, D00000191792, D00000191793, D00000191794, D00000191795, D00000191797, D00000191798, D00000191799, D00000191800, D00000191801, D00000191802, D00000191803, D00000191806, D00000191807, D00000191808, D00000191809, D00000191811, D00000191812, D00000191814, D00000191818, D00000191821, D00000191824, D00000191826, D00000191827, D00000191831, D00000191832, D00000191835, D00000191838, D00000191840, D00000191841, D00000191842, D00000191844, D00000191845, D00000191848, D00000191849, 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Distribution pattern

device · product 7 of 8

Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4) G5S-05A, (5) G5S-08A, (6) G5S-10A, (7) G5S-11A, (8) G5S-80A-TSO, (9) G5S-80-L (10) G5S-90A; 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.

Z-1322-2025

Recall number: Z-1322-2025
Initiated: February 13, 2025
Classification: Class II
Status: Ongoing
Recalling firm: ZOLL Medical Corporation
Quantity: 1312 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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).

Code information

Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4) G5S-05A, (5) G5S-08A, (6) G5S-10A, (7) G5S-11A, (8) G5S-80A-TSO, (9)G5S-80-L, (10) G5S-90A; UDI-DI: (1) no UDI, (2) 00812394021239, (3) no UDI, (4) no UDI, (5) no UDI, (6) no UDI, (7) no UDI, (8) 00812394021413, (9) no UDI, (10) no UDI; Serial Numbers: (1) D00000154575, D00000154617, (2) D00000003725, D00000003727, D00000003734, D00000003896, D00000003898, D00000003923, D00000003927, D00000003941, D00000003943, D00000003951, D00000003955, D00000003962, D00000003964, D00000003965, D00000003968, D00000003971, D00000003972, D00000003981, D00000003982, D00000003984, D00000003987, D00000003989, D00000003991, D00000003997, D00000003999, D00000004149, D00000004151, D00000004153, D00000004154, D00000004156, D00000004158, D00000004301, D00000004304, D00000004308, D00000004313, D00000004324, D00000004329, D00000004365, D00000004390, D00000004394, D00000004402, D00000004407, D00000004408, D00000004410, D00000004413, 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D00000055499, D00000055500, D00000055501, D00000055507, D00000055536, D00000055549, D00000055699, D00000055702, D00000055704, D00000055708, D00000055711, D00000055713, D00000059397, D00000059398, D00000059399, D00000059409, D00000059418, D00000059423, D00000059425, D00000060419, D00000060435, D00000060445, D00000060454, D00000060468, D00000060475, D00000060490, D00000060513, D00000063340, D00000063346, D00000063348, D00000063349, D00000063350, D00000063352, D00000063353, D00000063355, D00000063356, D00000063357, D00000063358, D00000063359, D00000063360, D00000063361, D00000063362, D00000063364, D00000063366, D00000063367, D00000063369, D00000063371, D00000063373, D00000063377, D00000063379, D00000063381, D00000063382, D00000063384, D00000063397, D00000063398, D00000063400, D00000063402, D00000063404, D00000063405, D00000063414, D00000063421, D00000063422, D00000063425, D00000063426, D00000063427, D00000063428, D00000063429, D00000063432, D00000063433, D00000063434, D00000063440, D00000063442, D00000063445, D00000063447, D00000063452, D00000063456, D00000063458, D00000065158, D00000065522, D00000065530, D00000065538, D00000065539, D00000065540, D00000065542, D00000065545, D00000065546, D00000065550, D00000065577, D00000065631, D00000065655, D00000065656, D00000065658, D00000065660, D00000065665, D00000065667, D00000065669, D00000065671, D00000065676, D00000065677, D00000065681, D00000065683, D00000065684, D00000065688, D00000065690, D00000065693, D00000065696, D00000065697, D00000065704, D00000065706, D00000065709, D00000065710, D00000065713, D00000065721, D00000065726, D00000065727, D00000065730, D00000065806, D00000065808, D00000065810, D00000065816, D00000065818, D00000065820, D00000065821, D00000065823, D00000065824, D00000065826, D00000065829, D00000065831, D00000065832, D00000065848, D00000065850, D00000065852, D00000065854, D00000065856, D00000065858, D00000065860, D00000065862, D00000065864, D00000065865, D00000065867, D00000065869, D00000065870, D00000065873, D00000065875, D00000065877, D00000065879, D00000065881, D00000065883, D00000065884, D00000065885, D00000065886, D00000065888, D00000065892, D00000065977, D00000066820, D00000066821, D00000066838, D00000066839, D00000066840, D00000068109, D00000068110, D00000068111, D00000068112, D00000068118, D00000068168, D00000068173, D00000068184, D00000068199, D00000068202, D00000068203, D00000068208, D00000068240, D00000068268, D00000068336, D00000068363, D00000068364, D00000069656, D00000069713, D00000069716, D00000069719, D00000069730, D00000070389, D00000070392, D00000070393, D00000070394, D00000070395, D00000070396, D00000070397, D00000070403, D00000070404, D00000070405, D00000070406, D00000070407, D00000070408, D00000070409, D00000070410, D00000070411, D00000070412, D00000070413, D00000070414, D00000070415, D00000070416, D00000070417, D00000070420, D00000070423, D00000070424, D00000070425, D00000071463, D00000071464, D00000071465, D00000071467, D00000071468, D00000071469, D00000071493, D00000073630, D00000073632, D00000073634, D00000073645, D00000073682, D00000073686, D00000073702, D00000073705, D00000073708, D00000073712, D00000073717, D00000073751, D00000073753, D00000073754, D00000074161, D00000074167, D00000074170, D00000074174, D00000074177, D00000074181, D00000074184, D00000074186, D00000074189, D00000074195, D00000074197, D00000074212, D00000074215, D00000074229, D00000074233, D00000075868, D00000075899, D00000075907, D00000075908, D00000075910, D00000075911, D00000075913, D00000075914, D00000075915, D00000075916, D00000075917, D00000075922, D00000075936, D00000075938, D00000075947, D00000075989, D00000076485, D00000076544, D00000076548, D00000077177, D00000077190, D00000077367, D00000077813, D00000077831, D00000077953, D00000077980, D00000078064, D00000078114, D00000078149, D00000078226, D00000078305, D00000078306, D00000078312, D00000078314, D00000078315, D00000078316, D00000078317, D00000078318, D00000078319, D00000078330, D00000078338, 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D00000087740, D00000087746, D00000087748, D00000087750, D00000087751, D00000087753, D00000087754, D00000087756, D00000087758, D00000087762, D00000087764, D00000089450, D00000089452, D00000089463, D00000089476, D00000089896, D00000089912, D00000089916, D00000089959, D00000089970, D00000089999, D00000090022, D00000090023, D00000090025, D00000090026, D00000090027, D00000090030, D00000090031, D00000090032, D00000090033, D00000090034, D00000090035, D00000090036, D00000090037, D00000090038, D00000090039, D00000090041, D00000090042, D00000090043, D00000090044, D00000090045, D00000090047, D00000090048, D00000090049, D00000090050, D00000090051, D00000090052, D00000090053, D00000090054, D00000090055, D00000090057, D00000090058, D00000090060, D00000090061, D00000090063, D00000090066, D00000090067, D00000090068, D00000090069, D00000090070, D00000090071, D00000090072, D00000090076, D00000090077, D00000090079, D00000090081, D00000090082, D00000090087, D00000090089, D00000090115, D00000092343, D00000092362, D00000092475, D00000092486, D00000094040, D00000094061, D00000094066, D00000094094, D00000094105, D00000094729, D00000094744, D00000094750, D00000094797, D00000097676, D00000097677, D00000097687, D00000097688, D00000097753, D00000097775, D00000097798, D00000097812, D00000097818, D00000099129, D00000099168, D00000099218, D00000099228, D00000099230, D00000099231, D00000099238, D00000099239, D00000099240, D00000099241, D00000099252, D00000099253, D00000099256, D00000099257, D00000099258, D00000099259, D00000099260, D00000099262, D00000099264, D00000099266, D00000099268, D00000099271, D00000099272, D00000099293, D00000099294, D00000099295, D00000099316, D00000099336, D00000099337, D00000099382, D00000099397, D00000099407, D00000099408, D00000100729, D00000100749, D00000101006, D00000101007, D00000101010, D00000101016, D00000101028, D00000101030, D00000101032, D00000101037, D00000101046, D00000101049, D00000103520, D00000103533, D00000103559, D00000103696, D00000103904, D00000103906, D00000103914, D00000103922, D00000103951, D00000103973, D00000103981, D00000103990, D00000103992, D00000103998, D00000104005, D00000104010, D00000104014, D00000112157, D00000112293, D00000112294, D00000120309, D00000124424, D00000124432, D00000124436, D00000130153, D00000130156, D00000130212, D00000131436, D00000131501, D00000131507, D00000132008, D00000143121, D00000143226, D00000143233, D00000143235, D00000143254, D00000143270, D00000143279, D00000143281, D00000143304, D00000143305, D00000143309, D00000143310, D00000143319, D00000143322, D00000143326, D00000143327, D00000143342, D00000143347, D00000143376, D00000143378, D00000143379, D00000143404, D00000143406, D00000143414, D00000143415, D00000143417, D00000143419, D00000143422, D00000143423, D00000143425, D00000143429, D00000143430, D00000143431, D00000143432, D00000143434, D00000143436, D00000143441, D00000143448, D00000143449, D00000143450, D00000143452, D00000143453, D00000143455, D00000143456, D00000143459, D00000143461, D00000143462, D00000143467, D00000143468, D00000143469, D00000143472, D00000143473, D00000143484, D00000143486, D00000143487, D00000143489, D00000143491, D00000143573, D00000143576, D00000146949, D00000147058, D00000147090, D00000147147, D00000147226, D00000147229, D00000147249, D00000147253, D00000147254, D00000147260, D00000147261, D00000147262, D00000147268, D00000147271, D00000147273, D00000147274, D00000147277, D00000147279, D00000147280, D00000147284, D00000147286, D00000147290, D00000147293, D00000147295, D00000147296, D00000147297, D00000147298, D00000147300, D00000147301, D00000147303, D00000147308, D00000147309, D00000147312, D00000147313, D00000147314, D00000147316, D00000147319, D00000147320, D00000147324, D00000147326, D00000147329, D00000147331, D00000147333, D00000147343, D00000147345, D00000147346, D00000147355, D00000147357, D00000147359, D00000147503, D00000147531, D00000147542, D00000147545, D00000147595, D00000147596, D00000147601, D00000147604, D00000147608, D00000147610, D00000147614, D00000147851, D00000149052, D00000149057, D00000149058, D00000149059, D00000149064, D00000149070, D00000149094, D00000149099, D00000149101, D00000149110, D00000149134, D00000149149, D00000149168, D00000149170, D00000149186, D00000149191, D00000149199, D00000149207, D00000149209, D00000149210, D00000149213, D00000149214, D00000149216, D00000150997, D00000151013, D00000151051, D00000151062, D00000151138, D00000151169, D00000151186, D00000151344, D00000152023, D00000152025, D00000152055, D00000155829, D00000155894, D00000158813, D00000159072, D00000159077, D00000159116, D00000159117, D00000159119, D00000163646, D00000163651, D00000163739, D00000163761, D00000165658, D00000173187, D00000173188, D00000173190, D00000173208, D00000173223, D00000173228, D00000173254, D00000173823, D00000173877, D00000175404, D00000176891, D00000176917, D00000178120, D00000178144, D00000178146, D00000178252, D00000178260, D00000178263, D00000178266, D00000178269, D00000178273, D00000178280, D00000178283, D00000178292, D00000178298, D00000178299, D00000178305, D00000178327, D00000178328, D00000178329, D00000178335, D00000178346, D00000178354, D00000178364, D00000178373, D00000180124, D00000181583, D00000181691, D00000182654, D00000183849, D00000183872, D00000184832, D00000185670, D00000185671, D00000185673, D00000185687, D00000185702, D00000185703, D00000185706, D00000185708, D00000185712, D00000185721, D00000185723, D00000185766, D00000185770, D00000185775, D00000185788, D00000185806, D00000185869, D00000185873, D00000185900, D00000186141, D00000191281, D00000191282, D00000191289, D00000191290, D00000191307, D00000191319, D00000191325, D00000191327, D00000191328, D00000191329, D00000191331, D00000191333, D00000191334, D00000191335, D00000191337, D00000191338, D00000191340, D00000191341, D00000191342, D00000191344, D00000191345, D00000191346, D00000191350, D00000191353, D00000191354, D00000191358, D00000191359, D00000191360, D00000191365, D00000191367, D00000191368, D00000191369, D00000191371, D00000191372, D00000191380, D00000191382, D00000191383, D00000191386, D00000191387, D00000191388, D00000191390, D00000191391, D00000191393, D00000191395, D00000191397, D00000191399, D00000191400, D00000191401, D00000191402, D00000191406, D00000191408, D00000191409, D00000191410, D00000191412, D00000191413, D00000191414, D00000191417, D00000191419, D00000191420, D00000191422, D00000191423, D00000191424, D00000191425, D00000191426, D00000191427, D00000191441, D00000191442, D00000191443, D00000191458, D00000191739, D00000191769, D00000191770, D00000191784, D00000192920, D00000193403, D00000193419, D00000193426, D00000193431, D00000193437, D00000194387, D00000194404, D00000195671, D00000203930, D00000223520, D00000223583, D00000223589, D00000223592, D00000223595, D00000223596, D00000223607, D00000223608, D00000223614, D00000223626, D00000224270, D00000224285, D00000240832, D00000252303, D00000270197, D00000270242, D00000270244, D00000270265, M00000002042, M00000015317, M00000015355, M00000015411, M00000015413, M00000015416, M00000015420, M00000015480, M00000015489, M00000015540, M00000015544, M00000015557, M00000015576, M00000015642, M00000015677, M00000015696, M00000015748, M00000015781, M00000015812, M00000015818, M00000015819, M00000015890, M00000015895, M00000015902, M00000015919, M00000015923, M00000015960, M00000015965, (3) D00000002496, D00000195191, (4) D00000228356, (5) D00000095452, (6) D00000023456, M00000001511, (7) M00000006322, (8) D00000247707, D00000247709, D00000247717, D00000247721, D00000247722, D00000247723, D00000247724, D00000247725, D00000247726, D00000247728, D00000247738, D00000247741, D00000247786, D00000247792, D00000247796, D00000247803, D00000247805, D00000247806, (9) D00000025111, D00000029078, (10) D00000035676, D00000176940;

Distribution pattern

device · product 8 of 8

Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80A; 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.

Z-1323-2025

Recall number: Z-1323-2025
Initiated: February 13, 2025
Classification: Class II
Status: Ongoing
Recalling firm: ZOLL Medical Corporation
Quantity: 8,744 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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).

Code information

Model/Catalog Number: G5S-80A; UDI-DI: 00812394021277; Serial Numbers: D00000003974, D00000004048, D00000004128, D00000004404, D00000004436, D00000004556, D00000004560, D00000004563, D00000004564, D00000004573, D00000004581, D00000004582, D00000004642, D00000004665, D00000004666, D00000004718, D00000004730, D00000004736, D00000004743, D00000004744, D00000004750, D00000004770, D00000004774, D00000004779, D00000004780, D00000004784, D00000004785, D00000004787, D00000004789, D00000004794, D00000004799, D00000004800, D00000004801, D00000004802, D00000004805, D00000004806, D00000004807, D00000004808, D00000004809, D00000004810, D00000004812, D00000004815, D00000004816, D00000004818, D00000004820, D00000004821, D00000004824, D00000004873, D00000004916, D00000004929, D00000004933, D00000004939, D00000004940, D00000004951, D00000004955, D00000004960, D00000004970, D00000004974, D00000004976, D00000004983, D00000006293, D00000006294, D00000006296, D00000006338, D00000006341, D00000006343, 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