Events

Recall of Device Recall BladderScan BVI 9600 or AortaScan AMI 9700

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Verathon, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72486
  • Event Risk Class
    Class 2
  • Event Number
    Z-1091-2016
  • Event Initiated Date
    2015-11-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141243
  • Notes / Alerts
    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.
  • Extra notes in the data
    System, imaging, pulsed echo, ultrasonic - Product Code IYO
  • Reason
    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
  • Model / Serial
    SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE USA ****************  A7001001, A7001002, A7001005, A7001007, A7001011, A7001022, A7001024, A7001031, A7001034, A7001036, A7001040, A7001041, A7001042, A7001043, A7001044, A7001045, A7001046, A7001047, A7001049, A7001050, A7001051, A7001052, A7001053, A7001054, A7001055, A7001056, A7001057, A7001060, A7001062, A7001065, A7001067, A7001068, A7001079, A7001080, A7001086, A7001088, A7001093, A7001094, A7001098, A7001101, A7001116, A7001117, A7001118, A7001119, A7001120, A7001121, A7001122, A7001123, A7001124, A7001125, A7001126, A7001127, A7001128, A7001129, A7001130, A7001131, A7001132, A7001138, A7001139, A7001140, A7001141, A7001143, A7001144, A7001146, A7001147, A7001148, A7001150, A7001151, A7001152, A7001153, A7001155, A7001156, A7001157, A7001158, A7001161, A7001162, A7001163, A7001164, A7001165, A7001168, A7001169, A7001170, A7001171, A7001172, A7001173, A7001174, A7001175, A7001176, A7001177, A7001178, A7001179, A7001180, A7001181, A7001182, A7001183, A7001184, A7001185, A7001186, A7001187, A7001188, A7001189, A7001190, A7001191, A7001192, A7001194, A7001195, A7001196, A7001197, A7001198, A7001199, A7001201, A7001202, A7001204, A7001205, A7001206, A7001207, A7001209, A7001210, A7001211, A7001212, A7001216, A7001217, A7001218, A7001219, A7001220, A7001221, A7001222, A7001223, A7001224, A7001226, A7001227, A7001228, A7001229, A7001231, A7001232, A7001233, A7001234, A7001235, A7001236, A7001237, A7001238, A7001239, A7001240, A7001241, A7001242, A7001243, A7001244, A7001246, A7001247, A7001248, A7001249, A7001250, A7001251, A7001252, A7001253, A7001254, A7001255, A7001256, A7001257, A7001258, A7001260, A7001261, A7001262, A7001264, A7001265, A7001266, A7001268, A7001269, A7001270, A7001271, A7001272, A7001273, A7001275, A7001276, A7001277, A7001278, A7001279, A7001281, A7001283, A7001284, A7001285, A7001286, A7001287, A7001288, A7001289, A7001290, A7001291, A7001292, A7001293, A7001294, A7001295, A7001296, A7001297, A7001298, A7001299, A7001300, A7001301, A7001302, A7001303, A7001305, A7001306, A7001307, A7001308, A7001312, A7001313, A7001314, A7001315, A7001316, A7001317, A7001318, A7001319, A7001320, A7001321, A7001322, A7001323, A7001324, A7001325, A7001326, A7001327, A7001328, A7001329, A7001330, A7001331, A7001332, A7001333, A7001334, A7001335, A7001336, A7001337, A7001338, A7001339, A7001340, A7001341, A7001342, A7001343, A7001344, A7001345, A7001347, A7001348, A7001349, A7001350, A7001351, A7001352, A7001353, A7001354, A7001355, A7001356, A7001357, A7001358, A7001359, A7001360, A7001361, A7001362, A7001363, A7001364, A7001365, A7001366, A7001367, A7001369, A7001370, A7001371, A7001372, A7001373, A7001375, A7001376, A7001377, A7001378, A7001380, A7001381, A7001382, A7001383, A7001384, A7001385, A7001386, A7001387, A7001388, A7001389, A7001390, A7001391, A7001392, A7001393, A7001394, A7001395, A7001396, A7001397, A7001398, A7001399, A7001400, A7001401, A7001402, A7001403, A7001404, A7001405, 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A7001614, A7001615, A7001616, A7001617, A7001618, A7001619, A7001620, A7001621, A7001622, A7001623, A7001624, A7001625, A7001626, A7001628, A7001629, A7001630, A7001631, A7001632, A7001633, A7001634, A7001635, A7001636, A7001637, A7001638, A7001639, A7001640, A7001641, A7001642, A7001643, A7001644, A7001645, A7001646, A7001647, A7001648, A7001649, A7001650, A7001651, A7001652, A7001653, A7001654, A7001655, A7001656, A7001657, A7001658, A7001659, A7001660, A7001661, A7001662, A7001663, A7001664, A7001665, A7001666, A7001667, A7001668, A7001669, A7001670, A7001671, A7001672, A7001673, A7001674, A7001675, A7001676, A7001677, A7001678, A7001679, A7001681, A7001683, A7001684, A7001685, A7001686, A7001687, A7001688, A7001689, A7001690, A7001691, A7001692, A7001693, A7001694, A7001695, A7001697, A7001698, A7001699, A7001700, A7001701, A7001702, A7001703, A7001704, A7001705, A7001706, A7001707, A7001708, A7001709, A7001710, A7001711, A7001712, A7001713, A7001714, A7001715, A7001716, A7001717, A7001718, A7001719, A7001721, A7001722, A7001723, A7001724, A7001725, A7001726, A7001727, A7001729, A7001730, A7001732, A7001733, A7001734, A7001735, A7001736, A7001737, A7001738, A7001739, A7001740, A7001741, A7001742, A7001743, A7001744, A7001745, A7001746, A7001747, A7001748, A7001749, A7001752, A7001753, A7001754, A7001755, A7001756, A7001757, A7001758, A7001759, A7001760, A7001761, A7001762, A7001763, A7001765, A7001766, A7001767, A7001768, A7001769, A7001770, A7001771, A7001780, A7001781, A7001782, A7001783, A7001784, A7001785, A7001786, A7001787, A7001788, A7001789, A7001790, A7001791, A7001792, A7001793, A7001794, A7001795, A7001800, A7001801, A7001802, A7001803, A7001804, A7001805, A7001806, A7001807, A7001808, A7001809, A7001810, A7001811, A7001812, A7001813, A7001814, A7001815, A7001816, A7001817, A7001819, A7001820, A7001821, A7001822, A7001823, A7001824, A7001825, A7001826, A7001827, A7001828, A7001836, A7001837, A7001841, A7001842, A7001843, A7001844, A7001845, A7001846, A7001847, A7001848, A7001857, A7001858, A7001859, A7001860, A7001861, A7001862, A7001863, A7001864, A7001865, A7001866, A7001867, A7001868, A7001869, A7001870, A7001871, A7001872, A7001873, A7001874, A7001876, A7001877, A7001878, A7001879, A7001880, A7001881, A7001882, A7001883, A7001884, A7001885, A7001886, A7001887, A7001888, A7001889, A7001890, A7001891, A7001892, A7001893, A7001894, A7001895, A7001897, A7001898, A7001899, A7001900, A7001901, A7001902, A7001903, A7001904, A7001905, A7001906, A7001907, A7001908, A7001909, A7001910, A7001911, A7001912, A7001913, A7001914, A7001915, A7001916, A7001917, A7001918, A7001919, A7001920, A7001921, A7001922, A7001923, A7001924, A7001925, A7001927, A7001928, A7001929, A7001930, A7001931, A7001932, A7001933, A7001934, A7001935, A7001936, A7001937, A7001938, A7001939, A7001940, A7001941, A7001942, A7001943, A7001944, A7001945, A7001946, A7001947, A7001948, A7001949, A7001950, A7001951, A7001952, A7001953, A7001954, A7001955, A7001956, A7001957, A7001958, A7001959, A7001960, A7001961, A7001962, A7001963, A7001964, A7001965, A7001966, A7001967, A7001968, A7001969, A7001970, A7001971, A7001972, A7001973, A7001981, A7300000, A7300001, A7300002, A7300003, A7300004, A7300005, A7300006, A7300007, A7300008, A7300012, B6001016, B6001020, B6001023, B6001024, B6001025, B6001026, B6001030, B6001040, B6001041, B6001043, B6001047, B6001049, B6001060, B6001065, B6001066, B6001068, B6001069, B6001070, B6001071, B6001073, B6001080, B6001082, B6001084, B6001085, B6001086, B6001088, B6001090, B6001092, B6001093, B6001094, B6001095, B6001096, B6001097, B6001098, B6001100, B6001102, B6001103, B6001104, B6001107, B6001108, B6001109, B6001110, B6001111, B6001112, B6001113, B6001123, B6001124, B6001130, B6001131, B6001133, B6001138, B6001140, B6001141, B6001143, B6001148, B6001157, B6001160, B6001164, B6001165, B6001166, B6001167, B6001168, B6001169, B6001170, B6001171, B6001172, B6001173, B6001174, B6001175, B6001176, B6001177, B6001178, B6001179, B6001180, B6001181, B6001183, B6001184, B6001185, B6001186, B6001187, B6001198, B6001199, B6001202, B6001203, B6001204, B6001205, B6001206, B6001207, B6001208, B6001209, B6001212, B6001213, B6001216, B6001217, B6001218, B6001219, B6001220, B6001221, B6001223, B6001225, B6001227, B6001231, B6001232, B6001234, B6001237, B6001238, B6001239, B6001241, B6001242, B6001243, B6001244, B6001245, B6001246, B6001254, B6001256, B6001257, B6001258, B6001259, B6001260, B6001261, B6001263, B6001265, B6001267, B6001269, B6001270, B6001271, B6001272, B6001273, B6001276, B6001277, B6001278, B6001279, B6001280, B6001281, B6001282, B6001283, B6001284, B6001285, B6001286, B6001287, B6001288, B6001298, B6001299, B6001305, B6001306, B6001307, B6001308, B6001309, B6001310, B6001311, B6001312, B6001313, B6001314, B6001315, B6001316, B6001317, B6001318, B6001319, B6001320, B6001321, B6001322, B6001323, B6001324, B6001325, B6001326, B6001327, B6001328, B6001329, B6001330, B6001331, B6001332, B6001339, B6001341, 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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.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    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
  • Product Description
    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.
  • Manufacturer Address
    Verathon, Inc., 20001 N Creek Pkwy, Bothell WA 98011-8218
  • Manufacturer Parent Company (2017)
    Roper Technologies Inc
  • Source
    USFDA