Events

Retiro De Equipo (Recall) de Gyroscan ACS-NT with software versions R6x, R7x, R8x

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 Philips Medical Systems.

¿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
    26580
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1227-03
  • Fecha de inicio del evento
    2002-11-21
  • Fecha de publicación del evento
    2003-09-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-01-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27923
  • 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
    System, Nuclear Magnetic Resonance Imaging - Product Code LNH
  • Causa
    Patient burns from cables near or in contact with the patient during use.
  • Acción
    On 11/21/02, the firm provided Field Change Order (FCO) 781 00006 to their field employees. This FCO instructed the field employees to visit the consignees and provide them with the addendums to the Instruction For Use Manual.

Device

Gyroscan ACS-NT with software versions R6x, R7x, R8x
  • Modelo / Serial
    6808, 87145, 86595, 50426, 100214, 101131, 63045, 103171, 41391, 38189, 37996, 85119, 84433, 83876, 102571, 86121, X1577, 44876, 86368, 44793, 87011, 101572, 100916, 82507, 85500, 13606, 86147, 76475, 86235, X1663, 38380, 101111, 37929, X1412, 86280, 37941, 38134, 101608, 25924, 84418, 101138, 6947, 86292, 83044, 63046, 86293, 86406, 102095, 50309, 87355, X1348, 101976, 76919, 17533, 37911, X0038, 26178, 85443, 101946, 13056, 41377, 76320, 59428, 84861, 14134, 76480, 101780, 50430, 50430, 50378, 13275, 85139, 45016, 87183, 86559, 102614, 102616, X1374, 101206, 83041, X1664, X1373, X1730, X1084, X1085, X1270, X1582, X1670, X1352, X1083, X1231, X1272, X1669, X1563, X1741, X0165, X1743, X1280, X1086, X0717, X1271, X0942, X0940, X1740, X1081, 86184, 83303, 101056, 103142, 83631, 38415, 59528, 59357, 83616, 101346, 102018, 76477, 38652, 101313, 38508, 50226, 76848, X1759, 86555, 86082, 14117, 86925, 86020, 13894, 103126, 83080, 101874, 17648, 82506, 86410, 86570, 82610, 38731, 17573, 87365, 62659, 82668, 102889, 41346, 87038, 84887, 103207, 86556, X1043, 87311, 52408, X1593, X1753, 83071, 101423, 100679, 38797, 6841, 47029, 13967, 86248, 13754, 101347, 50390, 102548, 87019, 44994, 87605, 101934, 83325, 41392, 86596, 101425, X1594, 82583, X1353, 83306, 25958, 86335, 86317, 76352, 40904, 10009, 85172, 83395, 103258, 45036, 86597, 37938, 100459, 41441, 13748, 38749, 14128, X1756, 101551, 13058, 87135, X1080, 102110, 38143, 37986, 83946, 82955, 100462, 85436, X0034, 62658, 76807, 76469, 25966, 13932, 102724, 87527, 86408, 101188, 38111, 44833, 41362, 41345, 38966, 26219, 26074, 82627, 86411, 85688, 85686, 82626, 87604, 50336, 86019, 87309, 13020, 84860, 38984, X1668, X1602, 13334, 13338, 13948, 102004, 76847, 102003, 6840, 87188, 26149, 13947, 80335, 83802, 10367, 10409, 38345, 85684, 50412, 50411, 100463, 86409, 83804, 38257, 86056, 87033, 45071, X1163, 101162, 102194, 87161, 87146, 84899, 59707, 13413, 85141, 10432, 13977, 58023, 103064, 87018, 86558, 86236, X1693, 102137, 86148, 103143, 84820, 38441, 87062, X0054, 102718, 26150, 103116, 100460, X1757, 82580, 100469, 38661, 86334, 101429, 76321, 101584, 103351, 41250, 85157, 44813, 86560, 82678, 85685, 14065, X1281, 82547, X1595, 41459, 85442, X1662, 41440, X1710, 38650, 101431, 86281, 101432, 83940, 86381, X0084, X1739, 47189, 87053, 38438, 86413, 100323, 10396, 76359, 76358, 17481, 17585, 17483, 17482, 82534, 100461, 86968, 83396, 10353, 86250, 86918, 100478, 83615, 101560, 41064, 13729, 101084, 47043, 17394, 13976, 14144, 84700, 87607, X1216, X1215, 13730, 13864, 100826, 50407, X1648, 17683, 13057, 13966, 87147, 82546, 38651, 86407, 59427, 84478, 84484, 87148, 59384, 59475, 103135, 62953, 86313, 59338, 83394, 59712, 86151, 86083, 62832, 83708, 87310, 26133, 82619, 87168, 87526, 87067, 83051, 101348, X1635, 103041, 102671, 102561, 83916, 38317, 103101, X0162, 84477, 26119, 100785, X1179, X1523, 86080, 85433, 38303, 38304, 86316, 44810, 40975, 83941, 45063, 50432, 101412, 87036, 102907, 45006, 102157, 101165, 101878, 85158, 47058, 41342, 13965, 73974, 86379, 41147, 84859, 102617, 101408, 83995, 83301, 38420, X1649, 86404
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The firm distributed units to hospitals and medical centers throughout the U.S.
  • Descripción del producto
    Gyroscan ACS-NT with software versions R6x, R7x, R8x
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Dirección del fabricante
    Philips Medical Systems, 22100 Bothell Everett Highway, Bothell WA 98041
  • Source
    USFDA