Events

Retiro De Equipo (Recall) de Device Recall Spectre Wireless Footswitch/Handswitch system

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 Trans American Medical, 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
    66064
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0532-2014
  • Fecha de inicio del evento
    2013-08-22
  • Fecha de publicación del evento
    2014-01-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-12-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121427
  • 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, Mobile - Product Code IZL
  • Causa
    Transamerican medical imaging is recalling certain lots of tmi spectre wireless footswitch/hand switch for ge oec 9800/9900 and philips fds and fdb cath labs due to potential safety issue related to the use of this product producing uncommanded x-ray.
  • Acción
    TransAmerican Medical sent an Urgent Medical Device Correction letter dated August 26, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that all potential users in their facility are made aware of the safety notification and the recommended actions. If the customers system does produce an uncommanded X-ray, turn the system off immediately. Remove the Spectre Wireless Footswitch and receiver and reinstall the standard OEM footswitch. Follow proper shutdown/system reboot instructions as indicated in the system operator's manual. Customers will be contacted to make arrangements for replacement of their TMi Spectre Wireless Footswitch at no charge. Customers will be provided a new TMI Spectre Wireless Footswitch and instructions on how to return the affected footswitch. Customers with questions were instructed to call 801-796-7335, ext 203.

Device

Device Recall Spectre Wireless Footswitch/Handswitch system
  • Modelo / Serial
    Serial numbers NS 10324 through NS 10392
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution: including states of: WA and UT.
  • Descripción del producto
    Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB. || The Spectre Wireless Encrypted Footswitch/Hand Switch System is a prescription use system and intended only for use with the system indicated in the model number
  • Manufacturer
    Trans American Medical, Inc.

Manufacturer

Trans American Medical, Inc.
  • Dirección del fabricante
    Trans American Medical, Inc., 965 W 325 N, Lindon UT 84042
  • Source
    USFDA