Events

LifeVest Wearable Defibrillator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Zoll Lifecor Corporation 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    56957
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0625-2011
  • 사례 출판 날짜
    2010-12-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-07-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95038
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Wearable automated external defibrillator - Product Code MVK
  • 원인
    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.
  • 조치
    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.

Device

LifeVest Wearable Defibrillator
  • 모델명 / 제조번호(시리얼번호)
    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,
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    Model 4000 Monitor component of the LifeVest Wearable Defibrillator
  • Manufacturer
    Zoll Lifecor Corporation

Manufacturer

Zoll Lifecor Corporation
  • 제조사 주소
    Zoll Lifecor Corporation, 121 Freeport Rd, Pittsburgh PA 15238-3411
  • Source
    USFDA