Events

Retiro De Equipo (Recall) de Tango Reflex

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 Laserex 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
    77170
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2172-2017
  • Fecha de inicio del evento
    2017-04-04
  • Fecha de publicación del evento
    2017-06-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155147
  • 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
    Powered laser surgical instrument - Product Code GEX
  • Causa
    It was discovered the unit produced a laser emission without pressing the fire button when the slit-lamp was driven to its lowest position prior to use on any patient.
  • Acción
    Ellex Medical shall, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard. 1. Installation of a spacer/collar to prevent the slit lamp from being lowered to the point where the cable can be crushed, 2. Improvement of cable management, 3. The corrections will be conducted at no cost to the purchaser, and 4. The corrective action will be completed by June 30, 2017. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. For further questions, please call (800) 824-7444.

Device

Tango Reflex
  • Modelo / Serial
    Serial No: TR 0010, TR 0095
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution
  • Descripción del producto
    Ellex Tango Reflex with slit lamp Laser Ophthalmic || In the SLT mode, the device is intended to be used for selective laser trabeculoplasty (ST) operations (laser trabeculoplasty for primary open angle glaucoma). In the VAG mode it is intended to be used to perform procedures requiring the rupture of tissue in the eye for Iridotomy and Iridectomy, Posterior capsulotomy and Posterior membranectomy.
  • Manufacturer
    Laserex Systems Inc.

Manufacturer

Laserex Systems Inc.
  • Dirección del fabricante
    Laserex Systems Inc., 7138 SHADY OAK RD, EDEN PRAIRIE MN 55344-3517
  • Source
    USFDA