Events

Retiro De Equipo (Recall) de Device Recall Skytron Ergon 2 Skyboom

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 Skytron, Div. The KMW Group, 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
    72897
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0655-2016
  • Fecha de inicio del evento
    2015-12-02
  • Fecha de publicación del evento
    2016-01-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-07-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142447
  • 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
    Table, operating-room, ac-powered - Product Code FQO
  • Causa
    The hardware that holds the vesa plate and the display interface / monitor to the bracket may fail causing the display interface to fall from the bracket. over time and with use the threaded rod hardware material can weaken and detach from the bracket. a display interface falling from its mounting location may result in injury to the patient or provider.
  • Acción
    Skytron sent an Urgent Medical Device Recall letter dated December 02. 2015, to all affected customers via certified mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers with questions were instructed to contact at 616-656-2900 with any questions. For after-hours support, please call 1-800-SKYTRON.

Device

Device Recall Skytron Ergon 2 Skyboom
  • Modelo / Serial
    Model Number(s): H8-010-50-FC2-LH and H8-010-50-FC2-RH. VESA plates distributed from 09/26/08 to 04/30/13.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including WI, TX, FL, NC, MD, OH, AZ, CA, UT, MT, OK, HI, CO, WY, MO, NJ, IL, NY, MA, IA, DE, PA, MI, IN, and WV and Internationally to Canada, and Japan.
  • Descripción del producto
    Ergon 2 Articulating Equipment Boom Monitor Brackets || mounting point for display interfaces utilized in clinical applications for viewing purposes and to provide an articulating point of movement on the ceiling mounted radial arm suspension system of the Ergon 2 equipment pendant / booms
  • Manufacturer
    Skytron, Div. The KMW Group, Inc

Manufacturer

Skytron, Div. The KMW Group, Inc
  • Dirección del fabricante
    Skytron, Div. The KMW Group, Inc, 5085 Corporate Exchange Blvd Se, Grand Rapids MI 49512-5515
  • Empresa matriz del fabricante (2017)
    The Kmw Group Inc
  • Source
    USFDA