Events

Rappel de Tango Reflex

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Laserex Systems Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    77170
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2172-2017
  • Date de mise en oeuvre de l'événement
    2017-04-04
  • Date de publication de l'événement
    2017-06-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-07-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155147
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Powered laser surgical instrument - Product Code GEX
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    Serial No: TR 0010, TR 0095
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution
  • Description du dispositif
    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.
  • Adresse du fabricant
    Laserex Systems Inc., 7138 SHADY OAK RD, EDEN PRAIRIE MN 55344-3517
  • Source
    USFDA