Events

Retiro De Equipo (Recall) de Device Recall Skytron Infinity series (also called Astro series) minor surgery light

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
    37120
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0525-2007
  • Fecha de inicio del evento
    2007-01-08
  • Fecha de publicación del evento
    2007-02-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-11-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49940
  • 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
    surgical light - Product Code FTD
  • Causa
    If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
  • Acción
    The firm initially notified consignees of this problem on 11/23/1999 and again on 11/01/2002 and most lights have already been corrected. Remaining consignees with lights in need of correction were notified of the problem via letter dated 1/8/07 and instructed to contact the distributor to have their lights inspected and modified.

Device

Device Recall Skytron Infinity series (also called Astro series) minor surgery light
  • Modelo / Serial
    Each lighthead bears a unique serial number. For units with model numbers beginning with IN 19, all seven digit serial numbers with the following numbers in the third and fourth positions of the numerical series: 95, 96, 97, 98 or 99 (example: xx95xxx) plus all eight serial numbers with a 0 in the fifth position (example: xxxx0xxx).
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and Canada.
  • Descripción del producto
    Skytron Infinity Series (also called Astro series) minor surgery light with dual lightheads, 3 bulbs in each of 2 - 19' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IN1919 and IN1919EL and IN1919EL/PT.
  • Manufacturer
    Skytron, Div. The KMW Group, Inc

Manufacturer

Skytron, Div. The KMW Group, Inc
  • Dirección del fabricante
    Skytron, Div. The KMW Group, Inc, 5000 36th St Se, Grand Rapids MI 49512-2008
  • Source
    USFDA