Device Recall ACUSON Antares Ultrasound sytem and premium edition

  • Model / Serial
    Serial numbers : 114792, 114819, 114822, 114827, 114829, 114839, 114843, 114844, 114845, 114846, 114847, 114848, 114849, 114851, 114859, 114860, 114861, 114863, 114864, 114871, 117874, 114876, 114880, 114881, 114882, 114885, 114890, 114891, 114894, 114895, 114909, 114910, 114912, 114918, 114921, 114927, 114928, 114930, 114931, 114935, 114941, 114944, 114947, 114948, 114949, 114953, 114957, 114958, 114959, 114960, 114962, 114963, 114971, 114977, 114978, 114730, 114735, 114745, 114761, 114781, 114785, 114826, 114865, 114868, 114869, 114896, 114936, 5000, 5001, 112919, 112925, 112971, 112980, 112981, 112984, 112989, 112992, 113005, 113009, 113013, 113015, 113037, 113040, 113041, 113042, 113045, 113048, 113051, 113052, 113053, 113055, 113058, 113061, 113067, 113068, 113075, 113076, 113079, 113080, 113101, 113102, 113105, 113143, 113145, 113147, 113204, 113225, 113257, 113259, 113302, 113407, 113411, 113414, 113462, 113469, 113566, 113682, 113706, 113715, 113759, 113767, 113803, 113825, 113826, 113827, 113828, 113829, 113831, 113832, 113834, 113835, 113841, 113843, 113846, 113847, 113848, 113849, 113850, 113851, 113852, 113856, 113863, 113873, 113900, 113917, 113921, 113945, 113947, 113950, 113957, 113980, 113986, 114014, 114043, 114052, 114061, 114164, 114172, 114176, 114186, 114233, 114254, 114255, 114271, 114274, 114313, 114351, 114356, 114363, 114406, 114461, 114474, 114475, 114481, 114482, 114493, 114536, 114573, 114583, 114584, 114590, 114596, 114587, 114602, 114612, 114614, 114616, 114617, 114621, 114640, 114644, 114647, 114652, 114655, 114661, 114665, 114669, 114671, 114675, 114687, 114690, 114694, 114699, 114703, 114706, 114716, 114721, 114728, 114734, 114732, 114740, 114742, 114743, 114744, 114749, 114751, 114753, 114754, 114755, 114757, 114759, 114760, 114762, 114764, 114768, 114770, 114771, 114773, 114775, 114777, 114782, 114789, 114790, 114791, 114792, 114793, 114794, 114796, 114799, 114802, 114805, 114807, 114808, 114809, 114810, 114811, 114813, 114818, 114819, 114820, 114821, 114822, 114825, 114827, 114828, 114829, 114831, 114833, 114834, 114835, 114836, 114838, 114842, 114843, 114844, 114844, 114845, 114846, 114847, 114848, 114849, 114850, 114851, 114853, 114857, 114859, 114860, 114861, 114863, 114864, 114866, 114870, 114873, 114878, 114886, 114899, 114901, 114908, 114914, 114916, 114920, 114926, 114937, 114939, 114940, 114943, 114945, 114950, 114955, 114973, 113322, 113904, 114228, 114415, 114524, 114528, 114566, 114568, 114623, 114630, 114632, 114635, 114636, 114645, 114646, 114651, 114672, 114685, 114717, 114723, 114724, 114725, 114726, 114727, 114729, 114733, 114736, 114737, 114739, 114741, 114746, 114747, 114748, 114750, 114752, 114758, 114769, 114765, 114766, 114767, 114779, 114780, 114783, 114784, 114786, 114788, 114795, 114797, 114798, 114800, 114801, 114803, 114804, 114806, 114812, 114814, 114816, 114823, 114824, 114830, 114832, 114837, 114840, 114841, 114852, 114854, 114855, 114858, 114862, 114867, 114868, 114869, 114872, 114875, 114877, 114879, 114887, 114888, 114889, 114892, 114893, 114897, 114898, 114900, 114902, 114903, 114904, 114905, 114907, 114911, 114913, 114915, 114919, 114922, 114923, 114924, 114925, 114929, 114933, 113249001, 113344001, 113458001, 113593001, 113731001, 113887001, and 113159001
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide: Product was distributed to medical facilities Nationwide including the states of OH, FL, IL, NY, CA, NH, TX, NJ, PA, MD, MO, GA, WA, WI, NE, WV, HI, MA, SC, MI, VA, AZ, UT, NH, RI, KY, SD, and IN, and internationally to Canada, Germany, Australia, Sweden, Saudi Arabia, Chile, South Korea, Mexico, France, UK, Taiwan, Singapore, Denmark, Brazil, New Zealand, Ireland, Belgium, Norway, Serbia, Vietnam, UK, Poland, China, Spain, South Africa, Austria, Croatia, Russia, Greece, Trinidad and Tobago, United Arab Emirates, India, Japan, Malaysia, Turkey, Thailand, Norway, Slovakia, Romania, Netherlands, Switzerland, Portugal, Italy, and Venezuela.
  • Product Description
    Siemens, ACUSON Antares, Ultrasound System (Standard and Premium Edition), 5.0 Systems with software version 200.0.054, P/N : 10032747 and 10032746 standard, 10032746, 10037591, and 10038202 for premium edition, Siemens, Ultrasound Division, Mountain View, CA 94039
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Siemens Medical Solutions USA, Inc., 1230 Shorebire Way, P.O. Box 7393, Mountain View CA 94043
  • Manufacturer Parent Company (2017)
  • Source
    USFDA