Events

Rappel de LifeVest Wearable Defibrillator

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Zoll Lifecor Corporation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    56957
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0625-2011
  • Date de publication de l'événement
    2010-12-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95038
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Wearable automated external defibrillator - Product Code MVK
  • Cause
    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.
  • 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.

Device

LifeVest Wearable Defibrillator
  • Modèle / numéro de série
    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,
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • 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.
  • Description du dispositif
    Model 4000 Monitor component of the LifeVest Wearable Defibrillator
  • Manufacturer
    Zoll Lifecor Corporation

Manufacturer

Zoll Lifecor Corporation
  • Adresse du fabricant
    Zoll Lifecor Corporation, 121 Freeport Rd, Pittsburgh PA 15238-3411
  • Source
    USFDA