Events

Retiro De Equipo (Recall) de Device Recall Sonesta 6210 Fluoroscopy Procedure Table

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 Stille AB.

¿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
    49407
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0119-2009
  • Fecha de inicio del evento
    2008-08-27
  • Fecha de publicación del evento
    2008-10-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-12-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73269
  • 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
    Radiographic Table - Product Code IXR
  • Causa
    The table contains a battery backup, not mentioned in the user manual, which automatically will provide power to the electrical actuators/motions in case of a power loss from the main power supply. however, if a short circuit occurs, it can result in an uncontrolled movement of the table which cannot be stopped by disconnecting the device from the main power supply, as the battery automatically w.
  • Acción
    Stille sent Field Safety Notices dated 8/27/08 to the direct accounts, informing them that the table contains a battery backup, not mentioned in the User Manual, which automatically will provide power to the electrical actuators/motions in case of a power loss from the main power supply. However, if a short circuit occurs, it can result in an uncontrolled movement of the table which cannot be stopped by disconnecting the device from the main power supply, as the battery automatically will supply continuous power to the control box. The accounts were requested to complete and return the enclosed acknowledgement card to Stille by fax or e-mail as soon as possible and no later than 9/26/08. The accounts were advised to not further use the table in conjunction with a C-arm or any other heavy object until a service technician can permanently remove the battery from the control box according to the enclosed Service Manual Amendment No. 1. Stille will make a permanent correction to the table once it has been validated and approved. Contact Stille Surgical Inc. at 1-800-655-1614 for assistance.

Device

Device Recall Sonesta 6210 Fluoroscopy Procedure Table
  • Modelo / Serial
    Model 6210, all serial numbers
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and Canada
  • Descripción del producto
    Sonesta 6210 Fluoroscopy Procedure Table; a motorized procedure table with adjustments (via a remote control) for height, tilt, back and seat cushion position; Stille Surgical AB, Sundbybergsvagen 1A, SE-17173 Solna, Sweden
  • Manufacturer
    Stille AB

Manufacturer

Stille AB
  • Dirección del fabricante
    Stille AB, Gardsvagen 14, Solna Sweden
  • Empresa matriz del fabricante (2017)
    Linc AB
  • Source
    USFDA