Events

Retiro De Equipo (Recall) de Device Recall Sonesta 6302 and 6302U

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
    53817
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0565-2010
  • Fecha de inicio del evento
    2009-11-03
  • Fecha de publicación del evento
    2009-12-23
  • 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=86579
  • 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
    Electric Cystometric Table - Product Code MMZ
  • Causa
    There is a potential hazard to the patient if the bolts holding the side rail break, causing the accessories attached at the side rails of the tables and chairs to fall off during a medical procedure.
  • Acción
    Stille sent Field Safety Notices dated 10/30/09 to the direct accounts, informing them that there is a potential hazard with the Sonesta tables if the bolts holding the side rail break, causing the accessories attached at the side rails of the tables and chairs to fall off during a medical procedure. Stille developed a retrofit kit consisting of six side rail bolts and instructions for installing the bolts, which were sent to the end users with the safety notice. The accounts were requested to replace the side rail bolts with the new bolts provided, and to complete and return the enclosed acknowledgement card to Stille by fax or e-mail as soon as possible and no later than 12/11/09. Contact Stille Surgical Inc. at 224-612-5404 for assistance.

Device

Device Recall Sonesta 6302 and 6302U
  • Modelo / Serial
    Model 6302, serial numbers 12-11075 and Model 6302U, serial numbers 12-11068, 12-11069, 12-11070, 12-11071, 12-11072, 12-11073, 12-11074, 12-11128, 12-11130, 12-11131, 12-11135, 12-11136, 12-11138, 12-11139, 12-11143, 12-11149; tables sold between 3/24/09 and 9/30/09
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- Including countries of USA and Canada.
  • Descripción del producto
    Stille Sonesta Gynecology and Urology Table 6302 and 6302U; an electric cystometric table; Stille AB, Solna, Sweden. || Used to position the subject/patient in a desired position during urodynamic, general examinations, cystoscopy, ultrasound, biofeedback, vasectomy and OBGYN procedures.
  • Manufacturer
    Stille AB

Manufacturer

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