Events

Retiro De Equipo (Recall) de Device Recall Extentrac Elite User Manual DCN: 14001

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 Advanced Back Technologies, 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
    71058
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1718-2015
  • Fecha de inicio del evento
    2015-05-13
  • Fecha de publicación del evento
    2015-06-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136934
  • 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
    Equipment, traction, powered - Product Code ITH
  • Causa
    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.
  • Acción
    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 User Manual DCN: 14001
  • Modelo / Serial
    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
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including CA, FL, NJ, TX, WA, Internationally: Korea, Russia, Kuwait, Canada, Greece, Lebanon, Turkey, Egypt, Saudi Arabia, China, Armenia, Azerbaijan, Australia.
  • Descripción del producto
    Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction)
  • Manufacturer
    Advanced Back Technologies, Inc.

Manufacturer

Advanced Back Technologies, Inc.
  • Dirección del fabricante
    Advanced Back Technologies, Inc., 89 Cabot Ct Ste F, Hauppauge NY 11788-3719
  • Empresa matriz del fabricante (2017)
    Advanced Back Technologies Inc
  • Source
    USFDA