Events

Rappel de Device Recall BladderScan BVI 9600 or AortaScan AMI 9700

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 Verathon, Inc..

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
    72486
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1091-2016
  • Date de mise en oeuvre de l'événement
    2015-11-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-10-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141243
  • 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
    System, imaging, pulsed echo, ultrasonic - Product Code IYO
  • Cause
    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).
  • Action
    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
  • Modèle / numéro de série
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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.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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
  • Description du dispositif
    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.
  • Adresse du fabricant
    Verathon, Inc., 20001 N Creek Pkwy, Bothell WA 98011-8218
  • Société-mère du fabricant (2017)
    Roper Technologies Inc
  • Source
    USFDA