Events

Retiro De Equipo (Recall) de Device Recall Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, TiltC, Prestige VH, Prestige SI, and Prestig

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 GE Healthcare, LLC.

¿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
    67125
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0804-2014
  • Fecha de inicio del evento
    2013-11-08
  • Fecha de publicación del evento
    2014-01-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-11-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124744
  • 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, x-ray, fluoroscopic, image-intensified - Product Code JAA
  • Causa
    Missing screws in the overhead video monitor suspension. ge discovered that the 4 outer screws that hold the overhead video monitor suspension to the carriage were missing since installation of the system. ge is not aware of any fall of the overhead monitor suspension.
  • Acción
    GE Healthcare Systems sent an " Urgent Medial Device Correction" letter dated November 7, 2013. The letter was addressed to Hospital Administrators / Risk Mangers, Managers of Radiology /Cardiology and Radiologists / Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (USA 800-437-1171, Japan 0120-055-919, For other countries, please contact your local GE Healthcare Service Representative).

Device

Device Recall Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, TiltC, Prestige VH, Prestig...
  • Modelo / Serial
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide including Washington D.C., Guam, and Puerto Rico. Outside the US to include: Afghanistan, Algeria, Argentina, Australia, Austria, Azerbaijan, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Burkina faso, Cameroon, Canada, Chile, China, Colombia, Costa Rica, Cote D'Ivoire, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Germany, Ghana, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Korea (Republic of), Kuwait, Lebanon, Libyan Arab Jamahiriya, Macedonia, Malaysia, Mali, Malta, Martinique, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Niger, Norway, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Yemen.
  • Descripción del producto
    Video Monitor Suspensions that may be on the following Fluoroscopic and Radiographic X-Ray systems: Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Prestige SII || Product Usage: || The systems are intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations on both adult and pediatric subjects. The systmes are used for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Dirección del fabricante
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA