Events

Retiro De Equipo (Recall) de Device Recall Visum LED Surgical Lights

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 Stryker Communications 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
    60812
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0913-2012
  • Fecha de inicio del evento
    2011-11-07
  • Fecha de publicación del evento
    2012-01-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106527
  • 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
    Light, surgical, ceiling mounted - Product Code FSY
  • Causa
    Stryker has identified a potential structural issue with the visum led surgical light(s). during a complaint investigation, stryker became aware that there was a possibility that incorrect assembly could result in the light head beginning to separate from the suspension arm. in the event the light separates and falls from the arm, it could lead to serious injury.
  • Acción
    The firm sent "Urgent: Medical Device Correction" letters dated 11/07/2011 to their domestic and international customers. The letter informed customers of the remote risk of the light detaching from the arm and recommended continued use of the product. A representative will contact them about scheduling an appointment to inspect the lights. Contact Technical Services at 1-866-841-5663 for questions.

Device

Device Recall Visum LED Surgical Lights
  • Modelo / Serial
    Catalog Number: 0682001250, 0682001251, 0682001252, and 0682001253.   Product Numbers: P10235 (Visum LED Surgical Light, Camera Ready), P10234 (Visum LED Surgical Light), P12875 (Visum LED Surgical Light Camera Ready - Low Ceiling), P12874 (Visum LED Surgical Light - Low Ceiling).   Expiration date: There is no expiration date with the scope of the action. Serial Numbers: Product manufactured between October 2010 to July 2011 and in use by customer.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA, and the countries of Australia, Canada, Hong Kong, Brazil, Sweden, India, Japan, Korea, Ecuador, Venezuela, Mexico, Denmark, Great Britain, and New Zealand.
  • Descripción del producto
    Visum LED Surgical Lights, Ceiling Mounted Surgical Light. The Visum LED surgical light is intended to illuminate the operative site during surgical procedures with high intensity light.
  • Manufacturer
    Stryker Communications Corp

Manufacturer

Stryker Communications Corp
  • Dirección del fabricante
    Stryker Communications Corp, 1410 Lakeside Pkwy Ste 100, Flower Mound TX 75028-4026
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA