Events

Retiro De Equipo (Recall) de Mettler Traction Decompression System, Model: ME 4000

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 Mettler Electronics Corp.

¿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
    58787
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2580-2011
  • Fecha de inicio del evento
    2011-04-14
  • Fecha de publicación del evento
    2011-06-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100298
  • 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
    The recall was initiated because mettler has confirmed the possible failure of internal mechanical component and software detection for potential failure regarding electronics traction device - mtd4000. the firm are initiating the recall because component failure might result in patient injury. use of the device should cease immediately.
  • Acción
    Mettler Electronics sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 14, 2011 to all affected consignees. The letter identified the product, the problem and the actions to be taken. Customers were instructed to immediately cease use of the recalled device, examine their inventory and quarantine product subject to recall. In addition, consignees were told if they have further distributed the affected product to please identify their customers and notify them at once of this product recall. The letter asks that that each includes a "Recall Return Response Form" that consignees are required to complete and return. If you have any questions please contact Mettler Electronics Corp 714-533-2221 x331, Monday through Friday, between the hours of 8:30 A.M. and 4:00 P.M. Pacific Time.

Device

Mettler Traction Decompression System, Model: ME 4000
  • Modelo / Serial
    Serial numbers beginning with 040, 050, 060, 070, 080, 090
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --USA (nationwide) and countries of Taiwan, Ireland and Haiti.
  • Descripción del producto
    MTD 4000 - Mettler Traction Decompression System, Model: ME 4000 || Product Usage: Provide traction and mobilization of skeletal structures and skeletal muscles
  • Manufacturer
    Mettler Electronics Corp

Manufacturer

Mettler Electronics Corp
  • Dirección del fabricante
    Mettler Electronics Corp, 1333 S Claudina St, Anaheim CA 92805
  • Empresa matriz del fabricante (2017)
    Mettler Electronics Corp.
  • Source
    USFDA