Events

Retiro De Equipo (Recall) de Device Recall Aplio

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 Toshiba American Med Sys 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
    37965
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0985-2007
  • Fecha de inicio del evento
    2007-02-02
  • Fecha de publicación del evento
    2007-06-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52530
  • 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
    Ultrasound - Product Code IYN
  • Causa
    When using the lv measurement function and making numerous measurements the value displayed on the image screen may on occasion not update correctly. the values that are stored in mda (measurement display area) are correct and no issue has been reported with these values.
  • Acción
    Notification letters were sent to customers on February 2, 2007. Customers were informed of the safety issue regarding the possibility of incorrect measurement values being displayed on the active image screen while performing multiple measurements and instructed to verify actual results against the values stored in the MDA (measurement display area). Customers were also informed that a Toshiba Customer Service Engineer will contact them to schedule a software upgrade when software becomes available. If customers have any questions they were instructed to contact their Toshiba Customer Service Engineer or call (800) 421-1968 and ask for the Regulatory Affairs Department. Customers were also instructed to distribute this information to all users of the product and also with the Bio-medical Department at their facility.

Device

Device Recall Aplio
  • Modelo / Serial
    Serial numbers:  80G0543625, 80G0543628, 80G0543636, 80G0543637, 80G0543639, 80G0543640, 80G0543643, 80G0543644, 80G0543645, 80G0583727, 80G0583728, 80G0583730, 80G0583731, 80G0593773, 80G0593785, 80G0593786, 80G0593789, 80G0593790, 80G0593791, 80G0593792, 80G0593793, 80G0593794, 80G05X3837, 80G05X3839, 80G05X3852, 80G05X3853, 80G05X3854, 80G05X3855, 80G05Y3866, 80G05Y3867, 80G05Y3870, 80G05Y3871, 80G05Y3872, 80G05Y3873, 80G05Y3874, 80G05Y3883, 80G05Y3884, 80G05Y3887, 80G05Y3889, 80G05Y3890, A1627001, A1627002, A1627003, A2532207, A2532209, A2532210, A2532211, A2542221, A2542223, A2542224, A2542225, A2542228, A2542229, A2542230, A2542232, A2542234, A2542235, A2542236, A2552260, A2552261, A2552262, A2552297, A2552298, A2552299, A2562305, A2562307, A2562309, A2592415, A2592420, A2602427,  A2602430, A2602432, A2602435, A2602436, A2602437, A2602438, A4583197, B3522582, B3532463, B3532464, B3532533, B3532534, B3532602, B3532603, B3542624, B3542625, B3542626, B3542627, B3542628, B3542629, B3552647, B3552648, B3552649, B3552651, B3552667, B3552669, B3552672, B3552673, B3562677, B3562678, B3562679, B3562680, B3562681, B3562694, B3562697, B3562700, B3572727, B3572732, C3592781, C3592783, C3592784, C3602834, C3602836, C3612855, C3612856, C3612857, C3612870, C36l 2872, C3612874, C3612875, C361 2877, C3612882, C3612883, C3612885, C3612886, C3612887, C3612888, C3612889, C3612891, C3612892, C3612893, C3612894, C3622938, C3622939, D3622940, D3622945, D3622947, D4532657, D4532658, D4532660, D4532663, D4533034,  D4533038, D4533039, D4533041, D4533042, D4533043, D4533044, D4533048, D4533051, D4533052, D4533054, D4533055, D4533056, D4543084, D4543085, D4543086, D4543088, D4543091, D4543092, D4543093, D4553108, D4553109, D4553111, D4553112, D4553121, D4553123, D4553124 D4553125, D4553126, D4563136, D4563141, D4563142, D4563143, D4573166, D4573167, D4573168, D4573169, D4573170, E4583194, E4583195, E4583196, E4583198, E4583201, E4583202, E4583206, E4583207, E4583208, E4583211, E4593250, E4593254, E4593255, E4593262, E4593263, E4593264, E4593267, E4593268, E4593270, E4593273, E4593274, E4593276, E4593278, E4593281, F4603311, F4603314, F4603317, F4613337, F4613338, F4613339, F4613341, F4613342, F4613343, F4613344, F4613351, F4613352, F4613353, F4613356, F4623375, F4623377, F4623378, F4623380, F4623381, F4623382, F4623383, F4623388, F4623389, F4623391, F4623392, F5513431, F5513433, F5513437, F5513439, F5513445, F5513446, F5513448, F5513449, F5513450, F5513452, F5513455, F5513460, F5513461, F5513462, F5513463, F5513464, F5513467,  F5513459, G5522743, G5523512, G5523513, G5523514, G5523519, G5523541, G5523544, G5523558, G5523559, G5523562, G5523563, G5523564, G5523565 & G5523567
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    Toshiba Aplio 80 Digital Ultrasound System, SSA-770A with version 6 software
  • Manufacturer
    Toshiba American Med Sys Inc

Manufacturer

Toshiba American Med Sys Inc
  • Dirección del fabricante
    Toshiba American Med Sys Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92781-2068
  • Source
    USFDA