Retiro De Equipo (Recall) de MCT 100/480 ISOTRAN PLUS (AKA TEAL Power Conditioning Unit)

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 (Cleveland) Inc.

¿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
    44721
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1234-2007
  • Fecha de inicio del evento
    2007-04-27
  • Fecha de publicación del evento
    2007-09-13
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2012-03-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Power conditioner - Product Code JAK
  • Causa
    The teal power conditioning units may fail and result in the unit emitting fire and/or smoke. note: the teal power conditioning unit has the potential to fail when the scanner that is attached to the teal is powered and in use as well as when not in use.
  • Acción
    On 9/04/2007, Philips Medical Systems (PMS) sent a letter via courier to all affected customers. The letter notified customers about the failures of the TEAL power conditioner and the possible emisson of fire and/or smoke from the units. In addition, the letter notes that PMS implemented a Field Change Order in May, 2007 that directs onsite repair of all affected units by PMS service technicians.

Device

  • Modelo / Serial
    Part Number: 4450028-01; Serial Numbers: 73343, 74482, 74481, 74480, 74477, 74478, 74479, 74639, 74637, 74640, 74638, 74641, 74758, 79281, 79279, 79282, 79278, 79280, 79348, 79347, 79345, 79346, 79512, 79513, 79514, 79511, 79515, 79582, 79699, 79698, 79696, 79697, 79700, 79778, 79774, 79776, 79773, 79775, 79772, 79777, 79898, 79899, 79893, 79894, 79892, 79897, 79896, 79891, 79895, 79976, 79980, 79978, 79975, 79977, 79979, 79974, 80060, 80132, 80125, 80127, 80123, 80124, 80131, 80161, 80128, 80130, 80129, 80126, 80571, 80570, 80574, 80579, 80577, 80572, 80573, 80578, 80575, 80576, 80729, 80730, 80894, 80895, 80896, 80934, 80932, 80897, 80931, 80933, 80935, 80848, 81007, 81004, 81008, 81005, 81010, 81009, 81006, 81090, 81091, 81095, 81093, 81089, 81092, 91094, 746390.  Part Number 4450028-02; Serial Numbers: 80583, 81116, 81121, 81117, 81115, 81119, 81128, 81118, 81120, 81126, 81122, 81123, 81125, 81127, 81124, 81129, 81168, 81165, 81169, 81167, 81166, 81170, 81179, 81177, 81171, 81175, 81176, 81351, 81354, 81347, 81348, 81349, 81353, 81350, 81346, 81355, 81352, 81173, 81174, 81172, 81178, 81446, 81454, 81458, 81459, 81455, 81448, 81445, 81449, 81447, 81456, 81457, 81453, 81451, 81452, 81450, 81826, 81830, 81827, 81829, 81828, 81851, 81853, 81852, 81854, 81855, 82053, 82054, 82051, 82052, 82050, 82114, 82112, 82113, 82116, 82119, 82115, 82117, 82120, 82121, 82118, 82154, 82156, 82155, 82157, 82153, 82267, 82266, 82273, 82268, 82265, 82269, 82274, 82271, 82272, 82270, 82387, 82386, 82385, 82383, 82384, 82472, 82473, 82476, 82474, 82475, 82519, 82521, 82518, 82517, 82520, 82604, 82600, 82598, 82603, 82602, 82599, 82607, 82605, 82606, 82601, 82705, 82708, 82707, 82704, 82706, 82798, 82797, 82801, 82799, 82800, 82928, 82927, 82926, 82924, 82925, 83010, 83011, 83012, 83014, 83013, 83109, 83108, 83107, 83106, 83115, 83112, 83110, 83111, 83113, 83114, 83156, 83157, 83158, 83159, 83160, 83155, 83161, 83164, 83162, 83276, 83269, 83272, 83273, 83163, 83271, 83274, 83275, 83277, 83270, 83278, 83381, 83378, 83380, 83375, 83377, 83373, 83374, 83379, 83382, 83376, 73546, 83543, 83548, 83543, 83547, 83544, 83549, 83550, 83551, 83552, 83675, 83676, 83673, 83678, 83681, 83679, 83677, 83674, 83672, 83680, 83748, 83746, 83745, 83744, 83747, 83882, 83878, 83875, 83876, 83877, 83880, 83883, 83884, 83879, 83881, 83881, 83884, 83879, 83880, 83883, 84010, 84014, 84009, 84013, 84008, 84011, 84012, 84016, 84007, 84015, 84065, 84064, 84066, 84072, 84071, 84070, 84069, 84067, 84068, 84073, 84209, 84211, 84212, 84213, 84207, 84210, 84208, 84215, 84216, 84236, 84239, 84233, 84237, 84231, 84235, 84238, 84240, 84232, 84234, 83672, 84519, 84517, 84514, 84516, 84515, 84513, 83877, 83878, 84518, 84520, 84523, 84525, 84526, 84521, 84524, 84522, 84527, 84597, 84598, 84595, 84599, 84596, 84600, 84849, 84854, 84853, 84852, 84850, 84848, 84855, 84851, 84857, 84856, 85014, 85007, 85012, 85006, 85010, 85011, 85009, 85015, 85005, 85016, 85008, 85013, 85017, 85004, 85003, 83678, 85148, 85151, 85149, 85154, 85156, 85152, 85150, 85155, 85157, 85253, 85256, 85258, 85259, 85257, 85254, 85252, 85255, 85153, 85262, 85261, 85260, 85263, 85265, 85264, 85266, 85281, 85282, 85283, 85284, 85286, 85289, 85290, 85287, 85285, 85288, 85320, 85318, 85314, 85313, 85317, 85321, 85316, 85322, 85323, 85325, 85327, 85319, 85333, 85324, 85326, 85332, 85347, 85330, 85315, 85349, 85348, 85336, 85335, 85334, 85337, 85351, 85340, 85353, 85350, 85355, 85339, 85356, 85374, 85352, 85354, 85372, 85371, 85373, 85379, 85378, 85377, 85376, 85375, 85380, 85790, 85791, 85792, 85786, 85785, 85793, 85788, 85784, 85787, 85789.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide, including, USA, Canada, China, Italy, Russia, Brazil, Belgium, Germany, Austria, Australia, Netherlands, France, Korea, Denmark, Israel, England, Argentina, Mexico, Spain, Yemen, Greece, Egypt, Japan, UAE, & Chile.
  • Descripción del producto
    The product is an isolation transformer, an accessory to Computed Tomography Scanner. It consists of electronic circuitry enclosed in a metal case. According to Philips Medical Systems, the metal case is manufactured from self-extinguishing materials. The unit is labeled in part, "Power Conditioner *** Part Number 4450028-XX *** Frequency: *** S/N: *** Rev: *** MFG date: *** INPUT RATINGS *** Model: MCT 100/480 ISOTRAN PLUS *** OUTPUT RATINGS *** MEDICAL POWER SUPPLY UL *** TEAL Electronics Corporation, San Diego, California ***".
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
  • Source
    USFDA