Events

Device Recall BladderScan BVI 9600 or AortaScan AMI 9700 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Verathon, Inc. 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
    72486
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1091-2016
  • 사례 시작날짜
    2015-11-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-10-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141243
  • 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
    System, imaging, pulsed echo, ultrasonic - Product Code IYO
  • 원인
    The firm is providing customers with an updated operations and maintenance manual for each of the bladderscan bvi 9600 and aortascan ami 9700 devices. the updated operations and maintenance manuals clarify that these devices should not be used for the screening, detection, or diagnosis of abdominal aortic aneurysms (aaas).
  • 조치
    Verathon sent an URGENT: MEDICAL DEVICE CORRECTION BLADDERSCAN BVI 9600 WITH AORTASCAN MODE & AORTASCAN AMI 9700 letter dated November 30, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Verathon will manage other international consignees outside Europe internally and follow a similar approach as the firm requested Stericycle to perform. Verathon will instruct the companys foreign distributors to communicate the Customer Correction Letter and provide the revised OMMs to their international customers. This current Medical Device Correction is intended to reinforce the message in the May 2014 communication regarding the potential variance in measurement and to provide you with updated Operation and Maintenance Manuals that further reinforce the devices intended use and indications for use and that revise warning information, including warnings specified in the May 2014 communication. Customers are instructed to destroy all existing Operations and Maintenance Manuals and replace them with updated versions and complete the information on the Medical Device Correction Reply Form and fax or email the completed form within 10 business days to: Fax: (877) 907-9956 or Email: verathon3108@stericycle.com. Customers with any questions can contact your Verathon representative or Verathon Customer Care at (866) 875-0382. Verathon has live agent support on Monday through Friday from 8am to 5 pm Pacific Time. Customers should report any suspected malfunction or adverse event related to any AortaScan AMI 9700 devices and any BladderScan BVI 9600 devices to Verathon Customer Care at (800) 331-2313

Device

Device Recall BladderScan BVI 9600 or AortaScan AMI 9700
  • 모델명 / 제조번호(시리얼번호)
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B6001598, B6001599, B6001600, B6001601, B6001602, B6001603, B6001604, B6001605, B6001606, B6001608, B6001609, B6001610, B6001611, B6001612, B6001613, B6001614, B6001615, B6001616, B6001617, B6001618, B6001619, B6001620, B6001621, B6001622, B6001623, B6001624, B6001627, B6001628, B6001629, B6001630, B6001631, B6001632, B6001633, B6001634, B6001635, B6001636, B6001637, B6001638, B6001639, B6001640, B6001641, B6001642, B6001643, B6001644, B6001645, B6001646, B6001647, B6001648, B6001660, B6001661, B6001662, B6001663, B6001664, B6001665, B6001666, B6001667, B6001668, B6001669, B6001670, B6001672, B6001673, B6001674, B6001675, B6001676, B6001677, B6001678, B6001679, B6001680, B6001681, B6001682, B6001683, B6001685, B6001686, B6001687, B6001688, B6001689, B6001691, B6001692, B6001693, B6001694, B6001695, B6001696, B6001697, B6001698, B6001699, B6001700, B6001701, B6001702, B6001703, B6001704, B6001705, B6001707, B6001708, B6001709, B6001710, B6001711, B6001712, B6001713, B6001715, B6001716, B6001717, B6001718, B6001719, B6001720, B6001721, B6001722, B6001723, B6001724, B6001725, B6001726, B6001727, B6001728, B6001729, B6001730, B6001731, B6001733, B6001734, B6001735, B6001736, B6001738, B6001739, B6001740, B6001741, B6001742, B6001743, B6001744, B6001746, B6001747, B6001748, B6001750, B6001751, B6001752, B6001753, B6001754, B6001755, B6001756, B6001757, B6001758, B6001759, B6001761, B6001762, B6001764, B6001765, B6001766, B6001767, B6001768, B6001769, B6001770, B6001771, B6001772, B6001773, B6001774, B6001776, B6001777, B6001778, B6001779, B6001780, B6001781, B6001782, B6001783, B6001787, B6001788, B6001790, B6001791, B6001793, B6001795, B6001796, B6001797, B6001798, B6001799, B6001800, B6001801, B6001803, B6001805, B6001806, B6001807, B6001808, B6001809, B6001810, B6001811, B6001812, B6001813, B6001814, B6001815, B6001816, B6001817, B6001818, B6001819, B6001820, B6001821, B6001822, B6001824, B6001825, B6001826, B6001827, B6001828, B6001829, B6001830, B6001831, B6001832, B6001833, B6001834, B6001835, B6001836, B6001838, B6001839, B6001840, B6001841, B6001842, B6001843, B6001844, B6001845, B6001846, B6001848, B6001849, B6001850, B6001851, B6001852, B6001853, B6001854, B6001855, B6001856, B6001857, B6001858, B6001859, B6001860, B6001861, B6001862, B6001863, B6001864, B6001865, B6001866, B6001867, B6001868, B6001869, B6001870, B6001871, B6001872, B6001873, B6001874, B6001875, B6001876, B6001877, B6001878, B6001879, B6001880, B6001881, B6001882, B6001883, B6001884, B6001885, B6001887, B6001888, B6001889, B6001890, B6001891, B6001892, B6001893, B6001894, B6001895, B6001896, B6001897, B6001898, B6001899, B6001900, B6001901, B6001902, B6001903, B6001904, B6001905, B6001906, B6001907, B6001908, B6001909, B6001910, B6001911, B6001912, B6001913, B6001914, B6001915, B6001916, B6001917, B6001918, B6001919, B6001920, B6001921, B6001922, B6001923, B6001924, B6001925, B6001926, B6001927, B6001928, B6001930, B6001931, B6001932, B6001934, B6001935, B6001936, B6001937, B6001938, B6001939, B6001940, B6001941, B6001942, B6001943, B6001944, B6001945, B6001946, B6001947, B6001948, B6001949, B6001950, B6001951, B6001952, B6001953, B6001954, B6001955, B6001956, B6001957, B6001958, B6001959, B6001960, B6001961, B6001962, B6001963, B6001964, B6001965, B6001966, B6001967, B6001968, B6001969, B6001972, B6001973, B6001974, B6001975, B6001976, B6001977, B6001978, B6001979, B6001980, B6001981, B6001982, B6001983, B6001984, B6001986, B6001987, B6001988, B6001989, B6001990, B6001991, B6001992, B6001993, B6001994, B6001995, B6001996, B6001997, B6001998, B6001999, B6002000, B6002001, B6002002, B6002003, B6002004, B6002005, B6002007, B6002008, B6002009, B6002010, B6002011, B6002012, B6002013, B6002014, B6002015, B6002016, B6002017, B6002018, B6002019, B6002020, B6002021, B6002022, B6002023, B6002024, B6002025, B6002026, B6002027, B6002028, B6002029, B6002030, B6002031, B6002032, B6002033, B6002034, B6002035, B6002036, B6002037, B6002038, B6002039, B6002040, B6002041, B6002042, B6002043, B6002044, B6002045, B6002047, B6002048, B6002049, B6002050, B6002051, B6002052, B6002054, B6002055, B6002057, B6002058, B6002059, B6002060, B6002061, B6002062, B6002063, B6002064, B6002065, B6002066, B6002067, B6002068, B6002069, B6002070, B6002071, B6002072, B6002073, B6002074, B6002075, B6002076, B6002077, B6002078, B6002079, B6002080, B6002081, B6002082, B6002083, B6002084, B6002085, B6002086, B6002087, B6002088, B6002089, B6002090, B6002091, B6002092, B6002093, B6002094, B6002096, B6002097, B6002098, B6002099, B6002100, B6002101, B6002102, B6002103, B6002104, B6002105, B6002106, B6002107, B6002108, B6002109, B6002110, B6002111, B6002112, B6002113, B6002114, B6002115, B6002116, B6002117, B6002118, B6002119, B6002120, B6002121, B6002122, B6002123, B6002124, B6002125, B6002126, B6002127, B6002128, B6002129, B6002130, B6002131, B6002132, B6002133, B6002134, B6002135, B6002136, B6002137, B6002138, B6002139, B6002140, B6002141, B6002142, B6002143, B6002145, B6002147, B6002148, B6002149, B6002150, B6002151, B6002152, B6002153, B6002154, B6002155, B6002156, B6002157, B6002158, B6002159, B6002160, B6002161, B6002162, B6002163, B6002164, B6002168, B6002169, B6002170, B6002171, B6002172, B6002173, B6002174, B6002175, B6002176, B6002177, B6002178, B6002179, B6002180, B6002181, B6002182, B6002183, B6002184, B6002185, B6002186, B6002187, B6002188, B6002189, B6002190, B6002191, B6002192, B6002193, B6002195, B6002196, B6002197, B6002198, B6002199, B6002200, B6002201, B6002202, B6002203, B6002204, B6002205, B6002206, B6002207, B6002208, B6002209, B6002210, B6002211, B6002212, B6002213, B6002214, B6002215, B6002216, B6002217, B6002218, B6002219, B6002220, B6002221, B6002222, B6002223, B6002224, B6002225, B6002226, B6002227, B6002228, B6002229, B6002230, B6002231, B6002232, B6002233, B6002234, B6002235, B6002236, B6002237, B6002238, B6002239, B6002240, B6002241, B6002242, B6002243, B6002244, B6002245, B6002246, B6002247, B6002248, B6002251, B6002252, B6002253, B6002254, B6002255, B6002256, B6002257, B6002258, B6002259, B6002260, B6002261, B6002262, B6002263, B6002264, B6002265, B6002266, B6002267, B6002268, B6002269, B6002270, B6002271, B6002272, B6002273, B6002274, B6002275, B6002276, B6002277, B6002278, B6002279, B6002280, B6002281, B6002282, B6002283, B6002284, B6002285, B6002286, B6002287, B6002288, B6002289, B6002292, B6002293, B6002294, B6002295, B6002296, B6002297, B6002298, B6002299, B6002300, B6002301, B6002302, B6002303, B6002304, B6002305, B6002306, B6002307, B6002308, B6002309, B6002310, B6002311, B6002313, B6002314, B6002315, B6002316, B6002317, B6002318, B6002319, B6002320, B6002321, B6002322, B6002323, B6002324, B6002325, B6002326, B6002327, B6002328, B6002329, B6002331, B6002332, B6002334, B6002335, B6002336, B6002337, B6002338, B6002339, B6002340, B6002341, B6002342, B6002343, B6002345, B6002346, B6002347, B6002348, B6002349, B6002350, B6002351, B6002352, B6002353, B6002354, B6002356, B6002357, B6002358, B6002359, B6002360, B6002361, B6002362, B6002363, B6002364, B6002365, B6002366, B6002367, B6002368, B6002369, B6002370, B6002371, B6002373, B6002374, B6002375, B6002376, B6002377, B6002378, B6002379, B6002381, B6002382, B6002383, B6002384, B6002385, B6002386, B6002387, B6002388, B6002389, B6002390, B6002391, B6002392, B6002393, B6002394, B6002395, B6002396, B6002398, B6002399, B6002401, B6002402, B6002403, B6002404, B6002405, B6002406, B6002407, B6002408, B6002411, B6002412, B6002413, B6002414, B6002415, B6002416, B6002417, B6002418, B6002419, B6002420, B6002421, B6002422, B6002423, B6002424, B6002425, B6002426, B6002427, B6002428, B6002429, B6002430, B6002431, B6002432, B6002433, B6002434, B6002435, B6002436, B6002437, B6002438, B6002439, B6002440, B6002441, B6002442, B6002443, B6002444, B6002445, B6002446, B6002447, B6002448, B6002449, B6002451, B6002452, B6002457, B6002458, B6002459, B6002460, B6002461, B6002462, B6002463, B6002469, B6002470, B6002471, B6002472, B6002473, B6002474, B6002475, B6002476, B6002477, B6002478, B6002479, B6002480, B6002481, B6002482, B6002483, B6002484, B6002485, B6002486, B6002487, B6002488, B6002489, B6002490, B6002491, B6002492, B6002493, B6002494, B6002495, B6002496, B6002504, B6002505, B6002506, B6002507, B6002508, B6002509, B6002510, B6002511, B6002512, B6002513, B6002514, B6002515, B6002519, B6002520, B6002521, B6002522, B6002524, B6002525, B6002526, B6002528, B6002529, B6002530, B6002531, B6002534, B6002535, B6002536, B6002542, B6002543, B6002544, B6002545, B6002546, B6002547, B6002548, B6002549, B6002550, B6002551, B6002553, B6002554, B6002555, B6002556, B6002557, B6002558, B6002559, B6002560, B6002561, B6002562, B6002563, B6002564, B6002565, B6002566, B6002602, B6002667, B6002668, B6002669, B6002670, B6002671, B6002672, B6002673, B6002674, B6002675, B6002676, B6002677, B6002678, B6002679, B6002680, B6002681, B6002682, B6002683, B6002684, B6002685, B6002686, B6002687, B6002688, B6002689, B6002690, B6002691, B6002692, B6002693, B6002694, B6002695, B6002696, B6002697, B6002698, B6002700, B6002701, B6002702, B6002703, B6002704, B6002705, B6002707, B6002708, B6002709, B6002710, B6002711, B6002712, B6002713, B6002714, B6002715, B6002716, B6002717, B6002718, B6002719, B6002720, B6002722, B6002723, B6002724, B6002725, B6002726, B6002727, B6002728, B6002729, B6002730, B6002732, B6002733, B6002734, B6002735, B6002736, B6002737, B6002746, B6002747, B6002748, B6002749, B6002750, B6002751, B6002752, B6002753, B6002754, B6002755, B6002756, B6002757, B6002758, B6002759, B6002760, B6002761, B6002762, B6002763, B6002764, B6002765, B6002766, B6002767, B6002768, B6002769, B6002770, B6002771, B6002772, B6002773, B6002774, B6002775, B6002777, B6002778, B6002779, B6002781, B6002782, B6002783, B6002784, B6002785, B6002786, B6002787, B6002788, B6002789, B6002790, B6002791, B6002792, B6002793, B6002794, B6002795, B6002796, B6002797, B6002798, B6002799, B6002800, B6002801, B6002803, B6002805, B6002806, B6002807, B6002808, B6002809, B6002810, B6002811, B6002812, B6002813, B6002815, B6002816, B6002817, B6002818, B6002819, B6002820, B6002821, B6002822, B6002823, B6002824, B6002825, B6002826, B6002827, B6002828, B6002829, B6002830, B6002831, B6002832, B6002833, B6002834, B6002835, B6002836, B6002837, B6002838, B6002839, B6002840, B6002841, B6002842, B6002843, B6002844, B6002845, B6002849, B6002857, B6002858, B6002859, B6002860, B6002861, B6002862, B6002863, B6002864, B6002865, B6002866, B6002867, B6002868, B6002869, B6002870, B6002871, B6002872, B6002873, B6002874, B6002875, B6002876, B6002878, B6002879, B6002880, B6002881, B6002882, B6002883, B6002884, B6002885, B6002886, B6002888, B6002889, B6002890, B6002891, and B6002892.   ****SERIAL NUMBERS OF UNITS DISTRIBUTED OUTSIDE THE USA*****  00001001, 00001007, 00001008, A7001048, A7001069, A7001071, A7001089, A7001090, A7001091, A7001092, A7001095, A7001096, A7001097, A7001100, A7001102, A7001103, A7001106, A7001107, A7001108, A7001109, A7001110, A7001111, A7001112, A7001113, A7001114, A7001115, A7001133, A7001136, A7001263, A7001280, A7001282, A7001442, A7001443, A7001444, A7001720, A7001796, A7001797, A7001798, A7001799, A7001829, A7001830, A7001831, A7001832, A7001833, A7001834, A7001835, A7001838, A7001839, A7001840, A7001849, A7001850, A7001851, A7001852, A7001853, A7001854, A7001855, A7001856, B6001063, B6001064, B6001075, B6001079, B6001081, B6001188, B6001189, B6001211, B6001224, B6001233, B6001251, B6001289, B6001294, B6001296, B6001300, B6001337, B6001347, B6001353, B6001368, B6001371, B6001380, B6001383, B6001391, B6001393, B6001394, B6001395, B6001405, B6001412, B6001413, B6001416, B6001418, B6001432, B6001446, B6001447, B6001454, B6001465, B6001466, B6001475, B6001476, B6001517, B6001534, B6001539, B6001540, B6001548, B6001551, B6001552, B6001556, B6001607, B6001625, B6001671, B6001684, B6001690, B6001714, B6001732, B6001745, B6001749, B6001760, B6001763, B6001775, B6001784, B6001785, B6001786, B6001789, B6001792, B6001802, B6001847, B6001886, B6001929, B6001933, B6001970, B6001971, B6001985, B6002053, B6002056, B6002166, B6002167, B6002194, B6002250, B6002290, B6002291, B6002330, B6002333, B6002344, B6002372, B6002409, B6002410, B6002450, B6002453, B6002454, B6002455, B6002456, B6002523, B6002532, B6002533, B6002552, B6002567, B6002568, B6002569, B6002570, B6002571, B6002572, B6002573, B6002574, B6002575, B6002576, B6002577, B6002578, B6002579, B6002580, B6002581, B6002582, B6002583, B6002584, B6002585, B6002586, B6002587, B6002588, B6002589, B6002590, B6002591, B6002592, B6002593, B6002594, B6002595, B6002596, B6002597, B6002598, B6002599, B6002600, B6002601, B6002603, B6002604, B6002605, B6002606, B6002607, B6002608, B6002609, B6002610, B6002611, B6002612, B6002613, B6002614, B6002615, B6002616, B6002617, B6002618, B6002619, B6002620, B6002621, B6002622, B6002623, B6002624, B6002625, B6002626, B6002627, B6002628, B6002629, B6002630, B6002631, B6002632, B6002633, B6002634, B6002635, B6002636, B6002637, B6002638, B6002639, B6002640, B6002641, B6002642, B6002643, B6002644, B6002645, B6002646, B6002647, B6002648, B6002649, B6002650, B6002651, B6002652, B6002653, B6002654, B6002655, B6002656, B6002657, B6002658, B6002659, B6002660, B6002661, B6002662, B6002663, B6002664, B6002665, B6002666, B6002706, B6002731, B6002738, B6002739, B6002740, B6002741, B6002742, B6002743, B6002744, B6002802, B6002804, and B6002877.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) and to the countries of : Guam, United Arab Emirates, Australia, Belgium, Canada , China, Czech Republic, France, Germany, Luxembourg, Netherlands, Norway, Saudi Arabia, Sweden , Taiwan, and United Kingdom
  • 제품 설명
    BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451. || AortaScan AMI 9700, Model Numbers: 0270-0636, 0270-0639, and U270-0636.
  • Manufacturer
    Verathon, Inc.

Manufacturer

Verathon, Inc.
  • 제조사 주소
    Verathon, Inc., 20001 N Creek Pkwy, Bothell WA 98011-8218
  • 제조사 모회사 (2017)
    Roper Technologies Inc
  • Source
    USFDA