Events

Retiro De Equipo (Recall) de Monitor Ceiling Suspension

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 Sales & Service Region No. America.

¿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
    27477
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0097-04
  • Fecha de inicio del evento
    2003-10-10
  • Fecha de publicación del evento
    2004-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-02-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29932
  • 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, X-Ray, Angiographic - Product Code IZI
  • Causa
    The thumbscrew hinge pin on the monitor support arm could become loose allowing the monitor to fall.
  • Acción
    The firm issued a letter dated October 10, 2003 to all affected customers. The suspension will be upgraded by field service personnel starting October 24, 2003.

Device

Monitor Ceiling Suspension
  • Modelo / Serial
    Part Numbers: 9807 605 71009, 9896 000 36771, 9896 000 36772. The firm uses site numbers as their serial numbers. Site Numbers: 76808, 6838, 35445, 38929, 62374, 41372, 74032, 17656, 44744, 50026, 44772, 38922, X0346, X0934, 41111, 38993, 6981, 6842, 59515, 6852, 6853, 44760, 67565, 62392, 74007, 44299, 44337, 41000, 25923, 35484, 37878, 6498, 44328, 41378, 45039, 41426, 62003, 37932, 13879, 25750, 41031, 76213, 62666, 62667, 76329, 44898, 41156, 37907, 38944, 45042, X0344, 38912, 40941, 46931, 62885, 13721, X0855, 6931, 46926, X1078, 47033, 44593, 100014, X1077, 76804, 44865, 13918, X0917, 76449, 74026, 6937, 6648, 25945, 35403, 25987, 35471, 73522, 47160, X1207, 50317, 47128, 6539, 76085, 17436, 59524, 47166, 17605, 50251, 76388, 47060, 26071, 73908, 62502, 62504, 62444, 67609, 67597, 67610, 37872, 37874, 62304, 6820, 44825, 41128, 62377, 73428, 13317, 61871, 41109, 26108, 26118, 41360, 6552, 26063, 59610, 59611, 37879, 37937, 37992, 73793, 25773, 25908, 26038, 26039, X0483, 35593, 67580, 37880, 45026, 62376, 6738, 35500, X0672, X0078, 16712, 16713, X0042, 16690, 17382, 17492, 76465, 46879, 35473, 62385, 59423, 13731, 50152, X0404, 35153, 67221, 67225, 68028, 68044, 68159, 67428, 59295, 59377, 13310, 62289, 59279, 59302, 59380, 47138, 50091, 6601, 6784, 6785, 37959, 6739, 67811, 37924, 34685, 35356, 59249, 59255, 17457, 17458, 67277, 68100, 45051, 46423, 34808, 40161, 47117, 47171, 13617, X0036, X0939, 34659, 41163, 41164, 25699, 52396, 52131, 59296, 61970, 31023, 35303, 25809, 35310, 40271, 46468, 43914, 41026, 62505, 25725, 62390, 73865, 74046, 59551, 17474, 62940, 37910, 38986, 67334, 67992, 62636, 62638, 38554, 59360, 61892, 15207, 62317, 13502, X0041, 6591, 25952, 41017, 59188, 67279, X0402, 76148, 62315, 62335, 6654, 25999, 25965, 25973, 15215, 74080, X0063, 25935, 25948, 25706, 25666, 25895, 50180, 62483, 62314, 38916, 35217, 13492, 25886, 59237, 59364, 46928, 13482, 73423, 73912, 15186, 50025, 67129, 76076, X0501, X1275, X1345, 4295, 6090, 6236, 6410, 46068, 58460, 59111, X0978, X1164, 104853, 67628, 73896, 62649, 62967, 46961, X0398, X0400, X0406, X0407, X0410, X0503, X0510, X0621, X0669, X0670, X0754, X0838, X0846, 62340, 73878, 49677, X0789, 67587, 61976, 34728, X0044, 25909, 59276, 46633, X1185, 59396, 44671, 73498, 41242, 44689, 35364, 104480, 25998, 62999, 47089, 26062, 16757, 44697, 17264, 13633, 13639, 37837, 44609, 59391, 25964, 37877, 37988, 13383, 13599, 44791, 17453, 25835, 25836, 25838, 13562, 6733, 76342, 6609, 6610, X0093, 37970, 26061, 59231, 25950, 73988, 44323, 40007, 73880, 35229, 62339, 38080, 25917, 6821, 44623, 13519, 10414, 25849, 6656, 6869, 59527, 74012, 76084, 44826, 44288, 44740, 62521, 13503, 25842, 34699, 44698, 52339, 59368, 62435, 62436, 67354, 47169, 47140, 62268, 26109, 6803, 40127, 44848, 50130, 59139, 59218, 59346, 13605, 6671, 59301, 73908, 68098, 17528, 35489, 62346, 74053, 50103, 61941, 67336
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The firm distributes to hospitals and medical centers.
  • Descripción del producto
    Monitor Ceiling Suspension for Fluoroscopic and Angiographic X-Ray Systems.
  • Manufacturer
    Philips Medical Systems Sales & Service Region No. America

Manufacturer

Philips Medical Systems Sales & Service Region No. America
  • Dirección del fabricante
    Philips Medical Systems Sales & Service Region No. America, 22100 Bothell Everett Highway, Bothell WA 98041
  • Source
    USFDA