Events

Retiro De Equipo (Recall) de Device Recall PoleStar N20 Magnetic Resonance Diagnostic Device

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 Odin Medical Technologies Ltd..

¿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
    56258
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2240-2010
  • Fecha de inicio del evento
    2010-07-01
  • Fecha de publicación del evento
    2010-08-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-11-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93082
  • 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
    Magnetic Resonance Diagnostic Device - Product Code LNH
  • Causa
    Electronic box on headstrap may overheat, causing burn to patient.
  • Acción
    Customers were notified by letter on 07/07/2010, advising them of the overheating problem and alerting them that a service rep will be visiting to inspect and upgrade any affected FlexiCoils. Questions were referred to 800-595-9709.

Device

Device Recall PoleStar N20 Magnetic Resonance Diagnostic Device
  • Modelo / Serial
    No lot numbers or serial numbers.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    CA, CO, DC, IL, IN, MD, MI, MN, MO, NE, NJ, NV, NY, OH, OR, WA, and WI. Foreign distribution to Austria, Belgium, Canada, China, France, Germany, Israel, Italy, Korea, Netherlands, Poland, Spain, Russia, Switzerland and Turkey.
  • Descripción del producto
    PoleStar FlexiCoil band D/E, revisions A and B, Catalog # 9733063, || Usage: Low field MRI device used to gather cranial images.
  • Manufacturer
    Odin Medical Technologies Ltd.

Manufacturer

Odin Medical Technologies Ltd.
  • Dirección del fabricante
    Odin Medical Technologies Ltd., Kochav Yokneam, 1 Hamelacha St., Yokneam Elit Israel
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA