Retiro De Equipo (Recall) de AD6 table for use with Integris and Integris Allura x-ray systems. The AD6 is the tilt version.

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 North America Co. Phillips.

¿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
    33873
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0207-06
  • Fecha de inicio del evento
    2005-10-12
  • Fecha de publicación del evento
    2005-11-29
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2011-03-09
  • 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
    System, X-Ray, Angiographic - Product Code IZI
  • Causa
    Potential for high voltage exposure involving the injector interface connector of patient support tables.
  • Acción
    On 10/10/05 the firm issued a letter to customers alerting customers to the problem and advising that the firm will perform an upgrade to the devices at customer sites. In March 2006 the firm issued a second notification letter involving more units.

Device

  • Modelo / Serial
    Site numbers: 530664, 519535, 532292, 533551, 538806, 532150, 504797, 504807, 504730, 533418, 536796, 534743, 532178, 520525, 504798, 504806, 534681, 534731, 536899, 522418, 536641, 533897, 534221, 505651, 530391, 530390, 532074, 535931, 536646, 539094, 522162, 536007, 535979, 536138, 504659, 536136, 540048, 539628, 519533, 535946, 533796, 538234, 504666, 531830, 505861, 505860, 540237, 506564, 536592, 532532, 536067, 505587, 535274, 532227, 535278, 520309, 537386, 537630, 506148, 530666, 521320, 521892, 530667, 533763, 530392, 533762, 538902, 531837, 531834, 520814, 537357, 521548, 534218, 521589, 105784, 536433, 536234, 530669, 532244, 520524, 521463, 535367, 521890, 520755, 520523, 532245, 535285, 534678, 536717, 532264, 534217, 506621, 530370, 538369, 534682, 530368, 534215, 530460, 505805, 534810, 535951, 538406, 538744, 538476, 538903, 537065, 534477, 534479, 536163, 534478, 536014, 104925, 534476, 532294, 522253, 520236, 519812, 504750, 536154, 536155, 530715, 535728, 534639, 535727, 534638, 538482, 538512, 506049, 536777, 104149, 531948, 519594, 519771, 531760, 535793, 533283, 519677, 533284, 538514, 506658, 533278, 533282, 506657, 533287, 533286, 533285, 534232, 506654, 522245, 506047, 506170, 532533, 532614, 520809, 532616, 506178, 532535, 535813, 532534, 532617, 532613, 534856, 532615, 532246, 521763, 539204, 522138, 520632, 535342, 531806, 504747, 531805, 521545, 521537, 533738, 532799, 532215, 522038, 521315, 520630, 104954, 535566, 104958, 531961, 538102, 538538, 103711, 535439, 104952, 537020, 534798, 521314, 520631, 104956, 104957, 104955, 522440, 506322, 105656, 105655, 537985, 104075, 531944, 521312, 534796, 535424, 540421, 105670, 522135, 531943, 521311, 505759, 104514, 104515, 521675, 104670, 531945, 535376, 536901, 521802, 520251, 506616, 506403, 531942, 530584, 531957, 531817, 531813, 506785, 538464, 521318, 522293, 504940, 538516, 534876, 521512, 532446, 531946, 505925, 533343, 520491, 534246, 531949, 532445, 505968, 536178, 538269, 535667, 531951, 536715, 536090, 535702, 534452, 534255, 505707, 522247, 522243, 520481, 522250, 505679, 531931, 506476, 505106, 505668, 532249, 536789, 505107, 537804, 535927, 531753, 535615, 534813, 531752, 538485, 538486, 538228, 521650, 520977, 538466, 534233, 105674, 537024, 521711, 534724, 533967, 105940, 505486, 104642, 539220, 105390, 519901, 521820, 519213, 538028, 533476, 534420, 534158, 520783, 530421, 531728, 537698, 520793, 104890, 532080, 533966, 536028, 533955, 536034, 536031, 536042, 532077, 536035, 533956, 536037, 534730, 533401, 105960, 538771, 534150, 519738, 534787, 534630, 520681, 500038, 534152, 506637, 535418, 520431, 520004, 504665, 520660, 519214, 521659, 535779, 105947, 535415, 535396, 519541, 521854, 520761, 536171, 103128, 506370, 105912, 519548, 534431, 538368, 520680, 534569, 506230, 105615, 506232, 536174, 519576, 536798, 534160, 536379, 534237, 519211, 520430, 540841, 539479, 539107, 506717, 538465, 536993, 537784, 535814, 505572, 521853, 500028, 500029, 522065, 520948, 520882, 506169, 519115, 532652, 522177, 532649, 537205, 505719, 504789, 534716, 504493, 504792, 532990, 535614, 534717, 506408, 519733, 534758, 534440, 519680, 534811, 540622, 522191, 534374, 535224, 522397, 506397, 519899, 538386, 519894, 105136, 533395, 505254, 505989, 540082, 500042, 519195, 105081, 105082, 105186, 533236, 537266, 519198, 535492, 520779, 533772, 532611, 533922, 537073, 531651, 532986, 532612, 522119, 532263, 535400, 522118, 105140, 105191, 505809, 533085, 533084, 103562, 537118, 506538, 105598, 102948, 103265, 534427, 531808, 103561, 531762, 540288, 537934, 538193, 538157, 506540, 506539, 532262, 520956, 103331, 530485, 505876, 103564, 539099, 104464, 533619, 103780, 102499, 540016, 537805, 102560, 538813, 105779, 521661, 533861, 103781, 535635, 522458, 535611, 533543, 519537, 532225, 519534, 504770, 537597, 538479, 534250, 539322, 521770, 521769, 105157, 505281, 521222, 535173, 534545, 534380, 538194, 535202, 537644, 534565, 533857, 536471, 535250, 536639, 534270, 534268, 536173, 537466, 534108, 521154, 534874.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Devices were distributed nationwide to hospitals/medical centers.
  • Descripción del producto
    AD6 table for use with Integris and Integris Allura x-ray systems. The AD6 is the tilt version.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA