Events

Retiro De Equipo (Recall) de Device Recall Xray Fluorescence

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 Olympus Scientific Solutions Americas.

¿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
    76208
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1036-2017
  • Fecha de inicio del evento
    2017-01-07
  • 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=152524
  • 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
    X-ray fluorescence - Product Code RBY
  • Causa
    It was discovered under rare circumstances the led warning light circuit could fail. if this happens, while the instrument is emitting x-rays during at test, the led warning lights will not illuminate. the test runs normally and will execute as before, but the light will not be on.
  • Acción
    Olympus will bring the defect compliance : 1. 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 recall coordinator noted below are to be included in the notification. 2. Tracking of customer/owner self-installation(s) of the software update should be done to the maximum possible extent via serial-number-tracked downloads, follow-up email reporting, return-mail card or by other similarly effective means. For further questions, please call (781) 419-3500.

Device

Device Recall Xray Fluorescence
  • Modelo / Serial
    affects all units.
  • Clase de dispositivo
    Not Classified
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of : PA, MA, CO, OH, NJ, GA, CA, TX, IL, VA, MN, NH, WA, SC, AZ, LA, MD, OK, IN, NY, NC and KS.
  • Descripción del producto
    Olympus Scientific Solutions Americas Corporation || (OSSA) VANTA¿ XRF Analyzer. Model Vanta VCR and Vanta VMR || Analytical X-ray systems
  • Manufacturer
    Olympus Scientific Solutions Americas

Manufacturer

Olympus Scientific Solutions Americas
  • Dirección del fabricante
    Olympus Scientific Solutions Americas, 48 Woerd Ave, Waltham MA 02453-3824
  • Empresa matriz del fabricante (2017)
    Olympus Corporation
  • Source
    USFDA