Events

Retiro De Equipo (Recall) de Device Recall ILED Surgical 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 Trumpf Medical Systems, 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
    51236
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1122-2009
  • Fecha de inicio del evento
    2009-02-27
  • Fecha de publicación del evento
    2009-04-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-10-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79361
  • 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
    Ceiling Mounted Surgical Light - Product Code FSY
  • Causa
    Cracks may form around the screw connections of the cover plates causing brittleness, which may lead to fragments breaking off and falling into the operating area.
  • Acción
    Consignees were notified via an Urgent Safety Information letter starting 02/27/2009. The Recall Notice asks customers to visually inspect the ILED covers for cracks and in particular to focus on the corners. If cracking is visible they are asked to remedy by taping with a clear tape over the cracks and report it to TRUMPF Medical Systems, Inc. immediately. TRUMPF will be replacing all covers with a newly designed and tested cover. Original priority in the United States will be set to start with the oldest units affected. If TRUMPF receives notification that cracking does exist then that facility will rise to the highest priority. Additionally, TRUMPF will issue a new approved cleaning and disinfection instruction, since investigations have shown that the cracking is significantly influenced by the use of certain disinfectants containing alcohol. The operator manual previously stated to avoid using alcohol-based cleaners on some parts of the ILED, but after reviewing this it was determined that it was not clearly stated to avoid use on the covers.

Device

Device Recall ILED Surgical Light

Manufacturer

Trumpf Medical Systems, Inc.
  • Dirección del fabricante
    Trumpf Medical Systems, Inc., 415 Jessen Ln, Charleston SC 29492
  • Empresa matriz del fabricante (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA