Zoll Lifecor Corporation: Model 4000 Monitor component of the LifeVest Wearable Defibrillator

Recall number

Z-0625-2011

Recalling firm

Zoll Lifecor Corporation

Product

Model 4000 Monitor component of the LifeVest Wearable Defibrillator

Status

Terminated

Initiated

2010-09-24

Posted

2010-12-16

Terminated

2012-07-05

Reason

The response button function may become intermittent. This can result in the device not progressing beyond the response button test during startup, which may prevent a conscious patient from delaying a treatment shock.

Root cause

Other

Action

Zoll Life Vest contacted patients that are expected to be in the device more than 60 days by letter and phone to arrange replacement monitors. Instructions for the return of the recalled monitor accompany the replacement monitor The firm will also contact the prescribing physician via telephone for long-term use patients to inform the physician of this voluntary recall and to assist in contacting any patients the firm was unable to reach by telephone. Zoll Life Vest can be contacted at 1-800-543-3267 about this recall.

Quantity

494 units

Distribution

Nationwide Distribution: Throughout the US. including the states of AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, and WV.

Lot, serial or model codes

product number 10A0988-A01; Serial number: 07000178, 07000196, 07000199, 07000202, 07000205, 07000211, 07000214, 07000223, 07000232, 07000241, 07000250, 07000265, 07000271, 07000289, 07000298, 07000301, 07000304, 07000307, 07000310, 07000313, 07000316, 07000325, 07000337, 07000343, 07000349, 07000355, 07000361, 07000373, 07000388, 07000397, 07000400, 07000409, 07000415, 07000427, 07000433, 07000436,  07000439, 07000448, 07000463, 07000466, 07000469, 07000472, 07000490, 07000496, 07000505, 07000511, 07000517, 07000520, 07000526, 07000529, 07000532, 07000538, 07000541, 07000574, 07000604, 07000628, 07000637, 07000646, 07000655, 07000658, 07000661, 07000697, 07000721, 07000730, 07000766, 07000769,  07000772, 07000784, 07000793, 07000796, 07000805, 07000808, 07000811, 07000820, 07000826, 07000838, 07000847, 07000853, 07000862, 07000877, 07000880, 07000883, 07000895, 07000898, 07000904, 07000913, 07000916, 07000919, 07000928, 07000937, 07000940, 07000943, 07000946, 07000955, 07000958, 07000976,  07000979, 07001006, 07001012, 07001018, 07001021, 07001024, 07001027, 07001030, 07001039, 07001042, 07001045, 07001066, 07001069, 07001072, 07001075, 07001081, 07001084, 07001087, 07001090, 07001105, 07001108, 07001111, 07001117, 07001120, 07001123, 07001126, 07001132, 07001138, 07001144, 07001147,  07001150, 07001153, 07001171, 07001174, 07001177, 07001180, 07001186, 07001195, 07001201, 07001204, 07001210, 07001216, 07001222, 07001225, 07001231, 07001234, 07001240, 07001243, 07001255, 07001270, 07001273, 07001285, 07001288, 07001291, 07001300, 07001303, 07001312, 07001315, 07001321, 07001324,  07001330, 07001333, 07001348, 07001360, 07001378, 07001381, 07001384, 07001387, 07001393, 07001396, 07001411, 07001414, 07001417, 07001423, 07001426, 07001432, 07001438, 07001441, 07001447, 07001450, 07001456, 07001462, 07001465, 07001483, 07001486, 07001492, 07001498, 07001510, 07001513, 07001525,  07001534, 07001543, 07001552, 07001564, 07001582, 07001594, 07001603, 07001606, 07001609, 07001615, 07001618, 07001624, 07001627, 07001630, 07001633, 07001636, 07001645, 07001648, 07001690, 07001696, 07001699, 07001702, 07001705, 07001708, 07001720, 07001723, 07001726, 07001735, 07001750, 07001753,  07001768, 07001780, 07001789, 07001804, 07001810, 07001813, 07001816, 07001828, 07001834, 07001837, 07001840, 07001843, 07001852, 07001855, 07001858, 07001861, 07001867, 07001870, 07001873, 07001879, 07001882, 07001885, 07001891, 07001897, 07001921, 07001924, 07001936, 07001942, 07001945, 07001951,  07001954, 07001957, 07001960, 07001963, 07001978, 07001981, 07001984, 07001999, 07002002, 07002008, 07002020, 07002032, 07002035, 07002047, 07002050, 07002071, 07002074, 07002077, 07002086, 07002089, 07002104, 07002110, 07002113, 07002119, 07002125, 07002134, 07002146, 07002149, 07002158, 07002167,  07002170, 07002173, 07002176, 07002179, 07002182, 07002185, 07002188, 07002191, 07002200, 07002212, 07002215, 07002227, 07002248, 07002251, 07002263, 07002266, 07002272, 07002278, 07002281, 07002287, 07002293, 07002299, 07002305, 07002308, 07002314, 07002317, 07002320, 07002329, 07002338, 07002344,  07002356, 07002365, 07002368, 07002380, 07002389, 07002392, 07002401, 07002413, 07002416, 07002428, 07002431, 07002437, 07002449, 07002455, 07002461, 07002467, 07002470, 07002473, 07002482, 07002488, 07002491, 07002494, 07002503, 07002512, 07002518, 07002524, 07002527, 07002530, 07002545, 07002548,  07002551, 07002554, 07002557, 07002563, 07002572, 07002575, 07002581, 07002593, 07002599, 07002602, 07002605, 07002611, 07002614, 07002623, 07002626, 07002629, 07002632, 07002650, 07002656, 07002659, 07002668, 07002671, 07002680, 07002683, 07002689, 07002692, 07002704, 07002707, 07002713, 07002722,  07002725, 07002728, 07002731, 07002752, 07002767, 07002776, 07002779, 07002785, 07002788, 07002791, 07002794, 07002800, 07002812, 07002815, 07002818, 07002821, 07002842, 07002845, 07002854, 07002857, 07002866, 07002869, 07002872, 07002875, 07002878, 07002881, 07002884, 07002899, 07002902, 07002905,  07002914, 07002929, 07002932, 07002935, 07002938, 07002941, 07002944, 07002950, 07002953, 07002962, 07002965, 07002968, 07002974, 07002983, 07002998, 07003004, 07003007, 07003010, 07003016, 07003022, 07003025, 07003028, 07003031, 07003043, 07003064, 07003070, 07003076, 07003079, 07003085, 07003088,  07003097, 07003106, 07003109, 07003112, 07003115, 07003118, 07003121, 07003133, 07003136, 07003142, 07003145, 07003151, 07003154, 07003157, 07003166, 07003169, 07003172, 07003175, 07003178, 07003184, 07003190, 07003193, 07003196, 07003199, 07003202, 07003205, 07003208, 07003211, 07003217, 07003220,  07003223, 07003238, 07003241, 07003253, 07003259, 07003268, 07003274, 07003280, 07003283, 07003292, 07003298, 07003301, 07003304, 07003310, 07003319, 07003322, 07003325, 07003328, 07003334, 07003337, 07003343, 07003352, 07003355, 07003361, 07003367, 07003370, 07003385, 07003391, 07003394, 07003400,  07003406, 07003409, 07003415, 07003424, 07003427, 07003430, 07003433, 07003460,

510(k) numbers

not on file

PMA numbers

["P010030"]

Product code

MVK

Firm FEI

3008642652

Firm city

Pittsburgh

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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