Events

Retiro De Equipo (Recall) de Device Recall ACHIEVA 1.5T and INTERA 1.5T Nuclear Magnetic Resonance Imaging

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
    52040
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0469-2011
  • Fecha de inicio del evento
    2009-05-01
  • Fecha de publicación del evento
    2010-11-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-01-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81965
  • 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
    Combined use of the synergy flex-m / shoulder coil 1.5t increases the chance of rf interaction and heating up of the coil. this may result in possible burns of the patient.
  • Acción
    Philips issued URGENT-Field Safety Notice letters dated May 1, 2009 and October 14, 2009 to their consignees. The letter informed customers that the firm will replace the "old" Flex M/Shoulder Coils with a new Flex-M coil. Consignees could contact Philips Healthcare Call Center at 800-722-9377, #5, #3, #1 and reference FCO 78100290 for any questions.

Device

Device Recall ACHIEVA 1.5T and INTERA 1.5T Nuclear Magnetic Resonance Imaging
  • Modelo / Serial
    Site Numbers:  10009, 10353, 10409, 10432, 13056, 13057, 13894, 17648, 25958, 25986, 26201, 26219, 26269, 35394, 37986, 38111, 38134, 38143, 38303, 38304, 38420, 38438, 38966, 41345, 41391, 45016, 50336, 59435, 59637, 59712, 62450, 62658, 62832, 63046, 76320, 76321, 76359, 76475, 76847, 82546, 82619, 83080, 83301, 83303, 83306, 83325, 83394, 83396, 83804, 83876, 83940, 83946, 83995, 84433, 84477, 84478, 84700, 84820, 84860, 84887, 84899, 85119, 85139, 85141, 85157, 85158, 85172, 85433, 85442, 85500, 85684, 85685, 85686, 85688, 86019, 86056, 86080, 86085, 86121, 86147, 86184, 86236, 86280, 86281, 86292, 86293, 86313, 86317, 86334, 86335, 86381, 86404, 86406, 86407, 86410, 86557, 86560, 86570, 86595, 86596, 86968, 87011, 87018, 87033, 87038, 87053, 87135, 87145, 87146, 87147, 87148, 87161, 87168, 87183, 87188, 87309, 87310, 87526, 87527, 87605, 87607, 100214, 100459, 100460, 100462, 100469, 100478, 100745, 100785, 100786, 100826, 100832, 100916, 101084, 101111, 101138, 101162, 101165, 101206, 101313, 101347, 101408, 101420, 101429, 101431, 101477, 101481, 101551, 101561, 101584, 101585, 101595, 101608, 101780, 101874, 101877, 101878, 101934, 101946, 101976, 102003, 102004, 102018, 102095, 102110, 102137, 102492, 102547, 102548, 102561, 102569, 102571, 102671, 102709, 102718, 102724, 102889, 102907, 102933, 102975, 102978, 102980, 103041, 103062, 103068, 103099, 103126, 103135, 103136, 103142, 103143, 103149, 103166, 103171, 103207, 103215, 103243, 103247, 103291, 103324, 103333, 103347, 103351, 103417, 103450, 103509, 103530, 103540, 103544, 103547, 103552, 103579, 103580, 103582, 103592, 103611, 103631, 103665, 103688, 103703, 103770, 103782, 103789, 103811, 103847, 103904, 103946, 104022, 104032, 104054, 104069, 104070, 104082, 104095, 104102, 104138, 104163, 104193, 104336, 104340, 104343, 104378, 104392, 104393, 104446, 104467, 104532, 104639, 104765, 104800, 104808, 104871, 104886, 104887, 104897, 104900, 104901, 104912, 104918, 104919, 104942, 105148, 105252, 105271, 105290, 105303, 105314, 105315, 105317, 105348, 105368, 105471, 105486, 105488, 105624, 105657, 105687, 105695, 105741, 105925, 105926, 105929, 105938, 225313, 250050, 250122, 250156, 250293, 250890, 500009, 500034, 504243, 504249, 504342, 504353, 504400, 504403, 504409, 504412, 504527, 504531, 504543, 504608, 504628, 504662, 504670, 504738, 504866, 505021, 505049, 505050, 505275, 505337, 505357, 505490, 505514, 505568, 505678, 505777, 505785, 505914, 505940, 505941, 505943, 506034, 506044, 506188, 506190, 506203, 506219, 506296, 506324, 506389, 506570, 506691, 506777, 519124, 519127, 519129, 519147, 519216, 519522, 519525, 519545, 520002, 520113, 520354, 520709, 521429, 530363, 530651, 531767, 533741, 536318, 536649, 542669, 544006, 544503, 545940, 546669, 547235, 550391, 556698, 557719, 557722, 557723, 557724, 557791, 557793, 557801, 557805, 557806, 557807, 557813, 557814, 557843, 557844, 557904, 558118, 558147, 558177, 558200, 558369, 558371, 558374, 558381, 558382, 41923351, and 43668550.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution: in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VA, WA, WI, WV, WY, and Washington DC. There were no foreign consignees.
  • Descripción del producto
    The product's marketing brochure states: "1.5T coils and accessories...Philips Achieva and Intera 1.5T MR systems". || The Identification of the Synergy Flex-M/ Shoulder Coil 1.5T can be found on the driver box. The 12nc of the affected system is labeled as 4522-131-6656x.
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

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