Events

Retiro De Equipo (Recall) de Device Recall Stationary Column TruSystem 7599

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 Trumpf 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
    75115
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0041-2017
  • Fecha de inicio del evento
    2016-07-10
  • Fecha de publicación del evento
    2016-10-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149390
  • 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
    Table, surgical with orthopedic accessories, ac-powered - Product Code JEA
  • Causa
    Three complaints describing trusystem tables unexpectedly descending approximately 20 centimeters.
  • Acción
    Trumpf Medical sent an Urgent Field Safety Notice dated July 8, 2015, to all affected consignees. The letter indicated that the tables should not be used until an authorized service engineer has exchanged the spindles of the affected operating tables. The letter included an acknowledgement form which is to be returned. The letter also requested a sub-recall if the product had been further distributed. For questions regarding this recall call 843-329-0543.

Device

Device Recall Stationary Column TruSystem 7599
  • Modelo / Serial
    Serial Numbers - 101863421, 101863427, 101863433, 101875827, 101879148, 101879149, 101882031, 101884650, 101884651, 101884653, 101884654, 101890658, 101890659, 101895636, 101904999, 101907202, 101907203
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including CA, CT, GA, IL, NC, OR, SC, VA, WI, WY, and Internationally to Australia, Azerbaijan, Brazil, Finland, France, Germany, Hungary, Italy, Luxembourg, Norway, Poland, Russia, Slovakia, and Switzerland
  • Descripción del producto
    Stationary Column TruSystem 7599, Material Number 1717020 || Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system.
  • Manufacturer
    Trumpf Medical Systems, Inc.

Manufacturer

Trumpf Medical Systems, Inc.
  • Dirección del fabricante
    Trumpf Medical Systems, Inc., 1046 Legrand Blvd, Charleston SC 29492-7672
  • Empresa matriz del fabricante (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA