Events

Rappel de Device Recall Extentrac Elite product brochure DCN: 13001, 09001

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 Advanced Back Technologies, 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
    71058
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1717-2015
  • Date de mise en oeuvre de l'événement
    2015-05-13
  • Date de publication de l'événement
    2015-06-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135953
  • 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
    Equipment, traction, powered - Product Code ITH
  • Cause
    Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for use in patients up to 300 lbs.
  • Action
    Advanced Back Technologies, Inc. sent an Urgent Medical Device Brocure & User Manual Recall letter dated May 13, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed the discard the DCN's identified as DCN 13-001, DCN 09-001, DCN 14-001 and replace with the newly issued DCN 15-001, DCN 15-002. The new DCN's would be provided to customers in pdf format via email for issuance. Customers were asked to contact their customers who purchased the affected product and inform them that they should not treat patients with a maximum weight exceeding 300 lbs until the firm is able to make an amendment to their 510(k). Customers with questions should call 631-231-0076.

Device

Device Recall Extentrac Elite product brochure DCN: 13001, 09001
  • Modèle / numéro de série
    Serial Numbers: 005, 006, 011, 017, 019, 0701101, 07071003, 07071004, 08031005, 08081006, 08091007, 09061009, 09091010, 09101011, 09101012, 10021014, 10031015, 10091017, 10121019, 11051020, 11061021, 11071022, 11091023, 12011026, 12081028, 13021028, 12091029, 12091030, 12121032, 13011033, 13101034, 13071037, 13031035, 14011038, 14041036 and 14061038
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including CA, FL, NJ, TX, WA, Internationally: Korea, Russia, Kuwait, Canada, Greece, Lebanon, Turkey, Egypt, Saudi Arabia, China, Armenia, Azerbaijan, Australia.
  • Description du dispositif
    Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for traction)
  • Manufacturer
    Advanced Back Technologies, Inc.

Manufacturer

Advanced Back Technologies, Inc.
  • Adresse du fabricant
    Advanced Back Technologies, Inc., 89 Cabot Ct Ste F, Hauppauge NY 11788-3719
  • Société-mère du fabricant (2017)
    Advanced Back Technologies Inc
  • Source
    USFDA