Events

Retiro De Equipo (Recall) de TCm monitoring system

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 Radiometer America 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
    35696
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1453-06
  • Fecha de inicio del evento
    2006-04-07
  • Fecha de publicación del evento
    2006-08-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46636
  • 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
    Monitoring system - Product Code KLK
  • Causa
    System shut down-when the tcm monitor is turned on and the booting process begins, the device stops after the memory count and will not proceed further.
  • Acción
    The firm began a recall/corrective action in response to this component defect on 4/7/2006, at which time, the firm issued a Field Action Notes memo (915-234). The firm is having their representatives: 1) assure that the use of the CompactFlashcards manufactured by Simple Tech has been discontinued at each customer location; 2) Replaace the CompactFlash card in all basic Units, 391-876, of R0036 through R0043; and 3) replace any spare part #914-698, which has been installed in Basic Units, 391--876, below R0036. Once completed, the firm has supplied their customers with a TELEFAX form to be completed, signed and dated by each customerand faxed back to Radiometer Medical ApS. The form documents that the instructions provided in theField Action Notes have been followed and that the necessary component replacements have been completed. The firm anticipates that the necesary corrective action will be completed by 7/1/2006.

Device

TCm monitoring system
  • Modelo / Serial
    TCM4 - Base Unit : Model: 391-876, Lot Numbrs R0036 thru R0043 (both inclusive). CompactFlash cards - Component: Model #914-698
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide-The recalled product was distributed to customers throughout the U.S. and Canada.
  • Descripción del producto
    TCM4 Series Monitoring System (Base Unit) 391-876 (affected device) CompactFlash cards: 914-698 (Defective Device Component)
  • Manufacturer
    Radiometer America Inc

Manufacturer

Radiometer America Inc
  • Dirección del fabricante
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1598
  • Source
    USFDA