Events

Rappel de TX1 Tissue Removal System

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 American Optisurgical 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
    65108
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1518-2013
  • Date de mise en oeuvre de l'événement
    2013-04-30
  • Date de publication de l'événement
    2013-06-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-03-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117897
  • 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
    Instrument, ultrasonic surgical - Product Code LFL
  • Cause
    American optisurgical, inc. is recalling certain lots of tx1 tissue removal system disposable handpiece due to inventory being released into distribution without a cleared fda 510(k) to cover recent product changes. use of this product may lead to an underperformance of the device.
  • Action
    American Optisurgical Inc. (AOI) sent an Urgent Medical Device Recall letter along with a response sheet via USPS registered mail to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately examine your inventory and quarantine product subject to recall. Once the product has been identified, return all products by FedEx to AOI using the AOI FedEx account 30655659-2, and referencing the Returned Goods Authorization (RGA) number:RGA# (to be assigned). For questions contact American Optisurgical Inc. Customer Service 949-580-1266.

Device

TX1 Tissue Removal System
  • Modèle / numéro de série
    Lot Numbers: 00312-07, 00713-06, 00912-01, 01813-02, 02413-04, 03113-02, 04213-01, 05113-01, 05113-02, 05512-03, 05713-03, 06313-05, 06512-08, 06513-02, 07213-04, 07912-06, 08212-07, 09412-03, 11412-06, 11612-05, 12912-04, 14512-07, 15312-03, 16412-07, 17412-01, 18712-06, 19812-13, 20212-03, 21412-03, 22212-03, 23412-06, 24112-06, 24212-04, 24912-13, 25712-01, 26912-01, 27712-05, 28512-03, 28912-03, 29612-01, 30512-02, 31112-05, 32112-03, 33112-01, 34712-05, 36612-01
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Disitribution - USA Nationwide in the states of Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming and the countries of Quezon City, Philippines, Singapore, and Panama City, Panama.
  • Description du dispositif
    TX1 Tissue Removal System disposable handpieces. || Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
  • Manufacturer
    American Optisurgical Inc

Manufacturer

American Optisurgical Inc
  • Adresse du fabricant
    American Optisurgical Inc, 26902 Vista Ter, Lake Forest CA 92630-8123
  • Source
    USFDA