Events

Retiro De Equipo (Recall) de XELERIS (1.0, 1.1, 2.0 & 2.1) PROCESSING AND REVIEW WORKSTATION

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
    56818
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0537-2011
  • Fecha de inicio del evento
    2010-10-27
  • Fecha de publicación del evento
    2010-12-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94580
  • 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, image processing, radiological - Product Code LLZ
  • Causa
    Ge healthcare has become aware of inaccurate user protocol setup associated with the thyroid uptake index application on certain xeleris workstations(1.0, 1.1, 2.0, 2.1) that may impact patient safety. inaccurate protocol setup by the user while using thyroid uptake index application has been identified on certain xeleris workstations. incorrect protocol setup during clinical data acquisition a.
  • Acción
    GE Healthcare sent an "Urgent Medical Device Correction" letter dated October 27, 2010, to all consignees. The letter was addressed to Hospital Administrators/Risk Managers, Managers of Radiology/Cardiology and Radiologists/Cardiologists and Identifed the product, the problem and the action to be taken by the consignees. Consignees were instructed to replace the original protocol instructions provided with their system with the updated protocol instructions provided with the letter. For any questions consignees were to contact their local GE Healthcare Service Representative or contact the GE Healthcare Call Center: United States or Canada (800) 437-1171 Other countries: (262) 896-2890

Device

XELERIS (1.0, 1.1, 2.0 & 2.1) PROCESSING AND REVIEW WORKSTATION
  • Modelo / Serial
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    All States in continental USA including DC and PR. Viet Nam, Venezuela, Uruguay, United Kingdom, Ukraine, Turkey, Thailand, Taiwan, Switzerland, Sweden, Spain, South Africa, Slovakia, Singapore, Saudi Arabia, Russian Federation, Republic of Korea, Portugal, Poland, Philippines, Panama, Pakistan, Norway, New Zealand, Netherlands, Morocco, Mexico, Martinique, Malaysia, Luxembourg, Kuwait, Kenya, Japan, Jamaica, Italy, Israel, Ireland, Indonesia, India, Hungary, Hong Kong, Guadeloupe, Greece, Germany, France, Finland, Ecuador, Dominican Republic, Cyprus, Colombia, China, Canada, Bulgaria, Brazil, Bosnia & Herzegovina, Belgium, Azerbaijan, Austria, Australia, Argentina, Algeria.
  • Descripción del producto
    XELERIS (1.0, 1.1, 2.0 & 2.1) PROCESSING AND REVIEW WORKSTATION || The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT) imaging, positron imaging by coincidence, attenuation correction, and anatomical image registration.
  • 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