Events

Retiro De Equipo (Recall) de iNX Wheeled Stretcher

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 Ferno-Washington 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
    71983
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2826-2015
  • Fecha de inicio del evento
    2015-08-03
  • Fecha de publicación del evento
    2015-10-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-01-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139518
  • 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
    Stretcher, wheeled - Product Code FPO
  • Causa
    Hole elongation in the telescoping load frame channel. a hole elongation could affect the ability of the retention pin to stay seated which is necessary to preclude movement of the telescoping load frame.
  • Acción
    Ferno began calling their customers on 8/3/2015. The firm informed their customers of the following: To provide optimal Customer Experience and minimal disruption to your service, the iNX field action involves the following steps: " Exchange of your current iNX with a new iNX; " Participation in a brief training session; and " Inspection of your Ferno Model 175 antler and rail fastening system as requested by the Dept. of Transportation. As you await delivery of your new iNX, it is important you ensure proper function of the fastening system and iNX telescoping load frame.

Device

iNX Wheeled Stretcher
  • Modelo / Serial
    Serial #s: 15F001703, 15F001704, 15F001706, 15F001707, 15F001708, 15F001709, 15F001710, 15F001711, 15F001712, 15F001713, 15F001715, 15F001717, 15F001719, 15F001721, 15F001722, 15F001723, 15F001724, 15F001725, 15F001726, 15F001727, 15F001728, 15F001729, 15F001730, 15F001731, 15F001732, 15F001733, 15F001734, 15F001735, 15F001736, 15F001737, 15F001738, 15F001739, 15F001740, 15F001741, 15F001742, 15F001744, 15F001745, 15F001746, 15F001747, 15F001748, 15F001749, 15F001750, 15F001751, 15F001752, 15F001753, 15F001754, 15F001755, 15F001756, 15F001757, 15F001758, 15F001759, 15F001760, 15F001761, 15F001762, 15F001763, 15F001764, 15F001765, 15F001766, 15F001767, 15F001768, 15F001769 5F001770, 15F001771, 15F001772, 15F001773, 15F001774, 15F001775, 15F001776, 15F001777, 15F001778, 15F001779, 15F001780, 15F001781, 15F001782, 15F001783, 15F001784, 15F001785, 15F001786, 15F001787, 15F001788, 15F001789, 15F001790, 15F001791, 15F001793, 15F001794, 15F001795, 15F001796, 15F001797, 15F001798, 15F001804, 15F001805, 15F001806, 15F001807, 15F001808, 15F001809, 15F001810, 15F001811, 15F001812, 15F001813, 15F001814, 15F001815, 15F001816 & 15F001850.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of: CO, IA, IL, IN, KY, MD, MN, MO, NC, NJ, NY, OH, OK, OR, TX, VA, WA & WY and the countries of CANADA, AUSTRALIA, UNITED KINGDOM & NEW ZEALAND.
  • Descripción del producto
    Ferno iNX Wheeled Stretcher, Integrated Patient Transport & Loading System || Product Usage: || Stretcher for pre-hospital patient transport.
  • Manufacturer
    Ferno-Washington Inc

Manufacturer

Ferno-Washington Inc
  • Dirección del fabricante
    Ferno-Washington Inc, 70 Weil Way, Wilmington OH 45177-9371
  • Empresa matriz del fabricante (2017)
    Ferno-Washington Inc.
  • Source
    USFDA