Events

Retiro De Equipo (Recall) de Device Recall Aplio XG model SSA790A

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 Medical Systems 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
    55941
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2981-2011
  • Fecha de inicio del evento
    2010-06-02
  • Fecha de publicación del evento
    2011-08-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92271
  • 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, imaging, pulsed echo, ultrasonic - Product Code IYO
  • Causa
    Toshiba america medical systems inc (tams) is initiating a field correction on the the aplio xg model ssa-790a because it did not meet the requirement of clause 15b, iec60601-1 which requires that the residual voltage shall not exceed 60v after 1 second from taking off the ac plug.
  • Acción
    Toshiba America Medical Systems (TAMS) sent an "URGENT:MEDICAL DEVICE CORRECTION' letter dated June 2, 2010 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were instructed to be careful not to touch the contacts or prongs on the AC plug within two seconds after unplugging the system from a wall socket. This precaution is to be adhered to until a Toshiba Service Representative replaces the power supply. Customers are to complete and return a Customer Reply Form and fax to 877-349-3054. Customers with questions regarding the notification should contact the Director of Regulatory Affairs at (800) 421-1968 or call their local Toshiba Representative at (800) 521-1968.

Device

Device Recall Aplio XG model SSA790A
  • Modelo / Serial
    4899 5131, 5132, 5133, 5134, 5224, 5139, 5260, 5261, 5369, 5256, 5367, 4883, 4884, 5370, 5374, 5375, 5264, 5257, 5135, 5223, 5379, 5262, 6283, 4886, 5258, 5382, 5383, 5384, 5385, 5216, 4887, 4897, 4898, 5027, 5380, 4982, 5026, 5137, 5138, 5219, 5220, 4979, 5465, 4900, 5466, 4978, 5377, 5136, 5376, 5072, 5071, 5221, 5215, 4981, 5371, 5372, 5373, 5029, 5030, 5068, 5069, 5070, 5222, 4980, 4885, 5259, 5028, 4896, 5368, 5217, 5218, 5140, 5265, 5364, 5365, 5366, 5381, 5467, 5468, 5469, 5470, 5471, 5472, 5473, 5474
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Aplio XG model SSA-790A || Aplio XG (SSA-790A) is a premium-class diagnostic ultrasound system incorporating state-of-the-art technologies. It is provided with the highest level of image quality and operability (reflecting the XG (next Generation) in its name), and can be used with ease for research as well as for routine clinical studies.
  • Manufacturer
    Toshiba American Medical Systems Inc

Manufacturer

Toshiba American Medical Systems Inc
  • Dirección del fabricante
    Toshiba American Medical Systems Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92781-2068
  • Empresa matriz del fabricante (2017)
    Canon Inc
  • Source
    USFDA