Events

Retiro De Equipo (Recall) de Device Recall Ultraview Digital Telemetry Transmitter

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Spacelabs Healthcare, Incorporated.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    48985
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1652-2008
  • Fecha de inicio del evento
    2008-07-18
  • Fecha de publicación del evento
    2008-09-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-03-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72451
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Telemetry Reciever - Product Code DSI
  • Causa
    Telemetry modules are failing to alarm for low heart rate and asystole.
  • Acción
    On 07/18/08 Spacelabs Healthcare issued a "URGENT-MEDICAL DEVICE CORRECTION" letter, dated July 16, 2008, to all customers who received the Spacelabs Medical Telemetry Receiver-Model 90478. The letter states circumstances in which the alarm fails, how to test each module for high rate alarm prior to patient use and a temporary work around if the alarm failure exists.` Letters have a receipt acknowledgement to ensure each customer receives the letter. Spacelabs Technical Support will personally install the new software, version V3.05.07EN, in all Spacelabs Medical Telemetry Receivers Model 90478. Technical Support will also be responsible for responding to customer technical questions and ensuring each customer is upgraded regarding this medical device recall. For assistance contact SpaceLabs Medical at 1-425-657-7200.

Device

Device Recall Ultraview Digital Telemetry Transmitter
  • Modelo / Serial
    Serial Numbers 478-111508, 478-111509, 478-111510, 478-111511, 478-111962, 478-111963, 478-111964, 478-111965 478-114831, 478-117016, 478-117395, 478-117602, 478-122332, 478-122333, 478-122535, 478-124039, 478-124040, 478-124042, 478-124055, 478-108923, 478-108924, 478-108925, 478-108926, 478-108927, 478-108928, 478-108929, 478-108930, 478-112419, 478-112420, 478-112421, 478-112422, 478-114943, 478-114944, 478-114945, 478-114946, 478-114947, 478-114948, 478-114949, 478-114950, 478-114951, 478-114952, 478-122698, 478-122704, 478-122711, 478-137602, 478-137603, 478-144927 478-122680, 478-122680, 478-122680, 478-122680, 478-128481, 478-128483, 478-128515, 478-128525, 478-112052, 478-113089, 478-113097, 478-113704, 470-110122, 478-110126, 478-110939, 478-110940, 478-113098, 478-113099, 478-113101, 478-120415, 478-122158, 478-122159, 478-122163, 478-124049, 478-124057, 478-124058, 478-124570, 478-124571, 478-124994, 478-124996, 478-113527, 478-113528, 478-113529, 478-113530, 478-113531, 478-113532, 478-113533, 478-113761, 478-111405, 478-111803, 478-111827, 478-111828, 478-111829, 478-111836, 478-111837, 478-111838, 478-111839, 478-111840, 478-111841, 478-111842, 478-111843, 478-111844, 478-111845, 478-111846, 478-111847, 478-111848, 478-111849, 478-111850, 478-111851, 478-111852, 478-111853, 478-111854, 478-111887, 478-111888, 478-111996, 478-112013, 478-112014, 478-112016, 478-118020, 478-118367, 478-119474, 478-119475, 478-122679, 478-122685, 478-122687, 478-122688, 478-122691, 478-122692, 478-124272, 478-124274, 478-124723, 478-124724, 478-124725, 478-124726, 478-124732, 478-124733, 478-124734, 478-124735, 478-124736, 478-124739, 478-124740, 478-124741, 478-124742, 478-124743, 478-124748, 478-124750, 478-124751, 478-124762, 478-127124, 478-127129, 478-127155, 478-127473, 478-127997, 478-128063, 478-128067, 478-128528, 478-114841, 478-114866, 478-114868, 478-114869, 478-114870, 478-114871, 478-114872, 478-114873, 478-105101, 478-105145, 478-105269, 478-105481, 478-105531, 478-105617, 478-105634, 478-106017, 478-110011, 478-110012, 478-110013, 478-110024, 478-110025, 478-111180, 478-115421, 478-113006, 478-113007, 478-113008, 478-113010, 478-115358, 478-117023, 478-117034, 478-117074, 478-118351, 478-118352, 478-122327, 478-122329, 478-123849, 478-123854, 478-123941, 478-123949, 478-128001 478-129153 478-120034, 478-120040, 478-120041, 478-120047, 478-106809, 478-106810, 478-105975, 478-110117, 478-110123, 478-115390, 478-115426, 478-116810, 478-116817, 478-116824, 478-117122, 478-117126, 478-117127, 478-118041, 478-118256, 478-124126, 478-124127, 478-124128, 478-124331, 478-125680, 478-125681, 478-125682, 478-128661, 478-128662, 478-128665, 478-128667, 478-129167, 478-129684, 478-129687, 478-129691 478-129949 478-132784, 478-132785, 478-127983, 478-127985, 478-127990, 478-127991, 478-127993, 478-127994, 478-127995, 478-128020, 478-107614, 478-107615, 478-107616, 478-107617, 478-107618, 478-107613, 478-100222, 478-100501, 478-105173, 478-105174, 478-108214, 478-108353, 478-108527, 478-108648, 478-128336, 478-128337, 478-128548, 478-128551, 478-128552, 478-128555, 478-128556, 478-128557, 478-127070, 478-127083, 478-128450, 478-128487, 478-110116, 478-110192, 478-110193, 478-110194, 478-110238, 478-130761, 478-131067, 478-131068, 478-131070, 478-131071, 478-131072, 478-130563, 478-130773, 478-130774, 478-130775, 478-130776, 478-130777, 478-130778, 478-130779, 478-130780, 478-130781, 478-130782, 478-131692, 478-131693, 478-132052, 478-132236, 478-132779, 478-132795, 478-132796, 478-132797, 478-132798, 478-132799, 478-132800, 478-132801, 478-132802, 478-134083, 478-134084, 478-134085, 478-134086, 478-134087, 478-134088, 478-134089, 478-134090, 478-134091, 478-131671, 478-132283, 478-132287, 478-132320, 478-132321, 478-132695, 478-132696, 478-132697, 478-132698, 478-132699, 478-132700, 478-132701, 478-132702, 478-132703, 478-132704, 478-132705, 478-132706, 478-132707, 478-132708, 478-132709, 478-132710, 478-132711, 478-132712, 478-132713, 478-132715, 478-132716, 478-132717, 478-132718, 478-132719, 478-132720, 478-132721, 478-132722, 478-132723, 478-132724, 478-132725, 478-132726, 478-132727, 478-132728, 478-132729, 478-133278, 478-133279, 478-133280, 478-133281, 478-133282, 478-133283, 478-133331, 478-133335, 478-133370, 478-133371, 478-133914, 478-133915, 478-133916, 478-133918, 478-133919, 478-133920, 478-133921, 478-133922, 478-133923, 478-133924, 478-133925, 478-133926, 478-133927, 478-133928, 478-133929, 478-133930, 478-133931, 478-133932, 478-133933, 478-133934, 478-133935, 478-133936, 478-133937, 478-133938, 478-133939, 478-133940, 478-133941, 478-133942, 478-133943, 478-133944, 478-133945, 478-133946, 478-133947, 478-133949, 478-134006, 478-134007, 478-134254, 478-134255, 478-130756, 478-130757, 478-130762, 478-130763, 478-130764, 478-133332, 478-133333, 478-133334, 478-133917, 478-133978, 478-133979, 478-133980, 478-133982, 478-130229, 478-130515, 478-130516, 478-130517, 478-130519, 478-132787, 478-132788, 478-132789, 478-139434, 478-132280, 478-132281, 478-132284, 478-132286, 478-132362, 478-132365, 478-132367, 478-132369, 478-132410, 478-132411, 478-132413, 478-132416, 478-132931, 478-132933, 478-132999, 478-133000, 478-133001, 478-133002, 478-133003, 478-133004, 478-133005, 478-133006, 478-133013, 478-133023, 478-133328, 478-133329, 478-133330, 478-134234, 478-134235, 478-134236, 478-134237, 478-134239, 478-134240, 478-134295, 478-134296, 478-134297, 478-134298, 478-134299, 478-134300, 478-134301, 478-134302, 478-134585, 478-134586, 478-134595, 478-134596, 478-134597, 478-134602, 478-134603, 478-134606, 478-136373, 478-136374, 478-136375, 478-136376, 478-136377, 478-136378, 478-136379, 478-136380, 478-136388, 478-136389, 478-136390, 478-136391, 478-136392, 478-136393, 478-136395, 478-136396, 478-136401, 478-136402, 478-136403, 478-136404, 478-136405, 478-136406, 478-136407, 478-136408, 478-136633, 478-136634, 478-136637, 478-136638, 478-109950, 478-124986, 478-124989, 478-125008, 478-125631, 478-125632, 478-141804, 478-141805, 478-141806, 478-141807, 478-141808, 478-141809, 478-141810, 478-141811, 478-141812, 478-141813, 478-141814, 478-141816, 478-143399, 478-143400, 478-143401, 478-143402, 478-146839, 478-146840, 478-146841, 478-146842, 478-146844, 478-146845, 478-146846, 478-146847, 478-146848, 478-146849, 478-146850, 478-146851 478-110624, 478-110968, 478-113052, 478-113053, 478-113090, 478-113091, 478-113092, 478-113093, 478-113094, 478-113111, 478-113112, 478-115377, 478-115395, 478-115397, 478-115400, 478-115402, 478-115404, 478-115405, 478-115417, 478-115418, 478-115419, 478-115420, 478-115422 478-113599, 478-113600, 478-117388, 478-117391, 478-118780, 478-118781, 478-118784, 478-118785, 478-122162, 478-122164 478-108544, 478-108545, 478-111549, 478-111550, 478-111552, 478-111555, 478-111557, 478-111558, 478-111559, 478-111560, 478-144585 478-117158, 478-117804, 478-117805, 478-117806, 478-117807, 478-117808, 478-117809, 478-117810, 478-117811, 478-122542, 478-122543 478-130293 478-111709, 478-111858, 478-111859, 478-111860, 478-111861, 478-111862, 478-115005, 478-115334, 478-116340, 478-117533, 478-117534, 478-117535, 478-117536, 478-117537, 478-117538, 478-117764 478-117134, 478-118259, 478-118260, 478-119686, 478-122224, 478-122225, 478-122226, 478-122231 478-125078, 478-128335, 478-128340 478-130301, 478-130882, 478-132238, 478-132248, 478-132268, 478-132282, 478-132285 478-109902, 478-109904, 478-109905, 478-109906, 478-109935, 478-109936, 478-110120, 478-110121, 478-110318, 478-110319, 478-111042, 478-111043 478-129946, 478-129947, 478-129951, 478-130520 478-128333, 478-128545, 478-128546, 478-128547, 478-129165, 478-129168, 478-129169, 478-129172 478-108772, 478-108777, 478-108789, 478-108931, 478-108932, 478-108933, 478-108935, 478-108936, 478-108937, 478-108938, 478-108939, 478-111823, 478-111824, 478-111825, 478-111826, 478-115437, 478-115438, 478-111894, 478-111895, 478-111896, 478-111897, 478-142240, 478-142241, 478-142242, 478-142243, 478-143973, 478-143978, 478-146906, 478-146907, 478-146908, 478-146910 478-106050, 478-106063 478-110203, 478-110450, 478-110458, 478-110598, 478-115844, 478-116162, 478-116163, 478-116271, 478-122862, 478-122873, 478-122875, 478-122876, 478-136422, 478-136423, 478-136424, 478-136425, 478-136426, 478-136427, 478-136428, 478-136431, 478-145278, 478-145322, 478-145323, 478-145552, 478-146101, 478-146167, 478-146952, 478-147043, 478-147070, 478-147153, 478-147164, 478-147165 478-112023, 478-113451, 478-113452, 478-113453, 478-113455, 478-113456, 478-113457, 478-113458, 478-113459, 478-119358, 478-119359, 478-122700, 478-122701 478-128338, 478-128339, 478-128341, 478-128342 478-112793, 478-112794, 478-116378, 478-124853, 478-126549, 478-126551, 478-126553, 478-126556, 478-126557, 478-126856, 478-126862, 478-126870, 478-126894 478-115231, 478-115234, 478-115287, 478-115293, 478-115294, 478-115295, 478-115296, 478-115351, 478-117720, 478-132714, 478-132732, 478-133975, 478-133976 478-125684, 478-125687 478-116797, 478-116798 478-145297, 478-145298, 478-145299, 478-145300, 478-145301 478-110493, 478-112048, 478-113096, 478-114216, 478-121458, 478-121459, 478-122161, 478-122165, 478-132730, 478-132731, 478-132733, 478-132734, 478-133326, 478-133327 478-141815, 478-142590, 478-142602 478-113727, 478-113795, 478-113796, 478-113798, 478-129381, 478-129796, 478-129797, 478-129883, 478-129884, 478-129885, 478-129886, 478-129887, 478-129888, 478-129889, 478-129890, 478-129892, 478-129355, 478-129444, 478-105999, 478-130223, 478-109741, 478-109763, 478-109773, 478-109774, 478-109775, 478-109776, 478-109777, 478-109778, 478-111498, 478-111612, 478-111613, 478-111614, 478-111615, 478-111617, 478-111657, 478-111702, 478-111705, 478-111733, 478-112260, 478-112262, 478-113287, 478-113535, 478-113536, 478-113537, 478-113538, 478-113539, 478-113540, 478-113541, 478-113542, 478-113543, 478-113544, 478-113545, 478-113546, 478-113547, 478-113549, 478-113550, 478-113551, 478-113552, 478-113553, 478-113554, 478-113555, 478-113556, 478-113557, 478-113558, 478-113559, 478-113560, 478-113561, 478-113562, 478-113563, 478-113564, 478-113565, 478-113566, 478-113567, 478-113568, 478-113569, 478-113570, 478-113571, 478-113572, 478-115448, 478-115471, 478-115473, 478-115474, 478-115475, 478-115476, 478-115477, 478-115478, 478-115479, 478-115480, 478-115481, 478-115482, 478-115484, 478-115485, 478-115486, 478-115487, 478-116892, 478-117203, 478-117204, 478-117205, 478-117264, 478-117306, 478-117307, 478-117308, 478-117309, 478-117542, 478-117913, 478-117914, 478-117915, 478-117916, 478-117917, 478-117918, 478-117919, 478-117920, 478-118563, 478-118564, 478-118565, 478-118566, 478-118567, 478-118568, 478-118569, 478-118570, 478-118571, 478-118572, 478-118573, 478-118574, 478-118575, 478-118576, 478-118577, 478-118578, 478-118579, 478-118580, 478-118581, 478-118582, 478-118855, 478-118948, 478-118949, 478-118950, 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  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and Internationally
  • Descripción del producto
    Ultraview Digital Telemetry Transmitter, Model 90478 || The Spacelabs Medical Digital Telemetry system provides continuous electrocardiographic (ECG) monitoring to detect ST segment changes, abnormal cardiac rhythms, including asystole, ventricular fibrillation and ventricular tachycardia.
  • Manufacturer
    Spacelabs Healthcare, Incorporated

Manufacturer

Spacelabs Healthcare, Incorporated
  • Dirección del fabricante
    Spacelabs Healthcare, Incorporated, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Source
    USFDA