Events

Retiro De Equipo (Recall) de Device Recall Metrotom 800

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 Carl Zeiss Metrology 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
    78885
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0379-2018
  • Fecha de inicio del evento
    2017-11-14
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160805
  • 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
    Cabinet x-ray, industrial - Product Code RCE
  • Causa
    Due to a software error, it was observed that when the user closes the access door, the system will resume its scan cycle automatically, instead of the user initiating x-ray generation from the control panel.
  • Acción
    Zeiss sent an Safety Notice Letter dated September 28, 2017, to the customers advising them of the recall. The affected device was identified as well as the issue involved. Customers are to complete and return the confirmation- waiver form. During the next scheduled service event, a ZEISS field service technician will update the Metrotom operating system. The corrections are to be made free of charge, and will be completed by March 2018. CDRH approves the CAP subject to the following conditions: Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. For further questions, please call (763) 203-4267.

Device

Device Recall Metrotom 800
  • Modelo / Serial
    Serial Numbers:  152806 157499 157683 181193 181364 182887 186654 186767 186797 192099 192182 192351 197342
  • Clase de dispositivo
    Not Classified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US, including the states of : WI, NC, GA, IL, AZ, FL, CA, NJ, and territory of PR; and the country of Canada.
  • Descripción del producto
    Metrotom 800 (130kV CT scanner) || Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal.
  • Manufacturer
    Carl Zeiss Metrology Inc

Manufacturer

Carl Zeiss Metrology Inc
  • Dirección del fabricante
    Carl Zeiss Metrology Inc, 6250 Sycamore Ln N, Maple Grove MN 55369-6310
  • Empresa matriz del fabricante (2017)
    Carl-Zeiss-Stiftung
  • Source
    USFDA