Events

Retiro De Equipo (Recall) de Device Recall IMRIS intraoperative MRI Systems: Neuro IISE, Neuro IIISV, iMRI 1.5T A, iMRI 3TS

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 Deerfield Imaging.

¿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
    73421
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1098-2016
  • Fecha de inicio del evento
    2016-02-10
  • Fecha de publicación del evento
    2016-03-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-04-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144171
  • 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
    System, nuclear magnetic resonance imaging - Product Code LNH
  • Causa
    Emergency helium venting lines (i.E. quench lines) may not have been properly installed.
  • Acción
    Consignees were sent a IMRIS "Urgent Field Safety Notice" letter dated February 10, 2016. The letter described the problem and the product involved in the recall. The firm also stated that it is important that customers review the portion of the quench line vent described and ensure that it is installed to the specifications supplied as part of the Planning Guide. Customers were reminded that it is important to have an emergency plan in place in the event Helium gas escapes into the magnet room or any other area. For questions customers can contact their local customer support hotline or +1-866-475-0525.

Device

Device Recall IMRIS intraoperative MRI Systems: Neuro IISE, Neuro IIISV, iMRI 1.5T A, iMRI 3TS
  • Modelo / Serial
    70036, 10076-21, M00004, 10073-01, 23529, 40481, M00152, M00005, 30445, M00169, 060014, 10043-00, 30823, 10004680, 10050-01, 40662, 30935, 31084, 31203, 10002221, 40510, 40613, 30719, 31046, 30910, 30832, 30623, 31213, 10004152, 10072-01, 31250, 40815, 31049, 30068, 40412, M0038, M00106, M00367, 10035-01, 40475, 40495, 10007498, 10005946, 40263, 40688, 10058-00, 40619, 31085, and 10005639.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US, including the states of CA, CT, FL, GA, IL, IN, MD, MA, MN, MO, NH, NC, OH, OR, PA, TX, UT, VA, and WI; and ,countries of CHINA, CANADA, AUSTRALIA, FRANCE, JAPAN, and GERMANY.
  • Descripción del producto
    Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. || Indicated for use as a magnetic resonance diagnostic device (MRDD).
  • Manufacturer
    Deerfield Imaging

Manufacturer

Deerfield Imaging
  • Dirección del fabricante
    Deerfield Imaging, 5101 Shady Oak Rd S, Minnetonka MN 55343-4100
  • Empresa matriz del fabricante (2017)
    Deerfield Management Company L.P.
  • Source
    USFDA