Events

Retiro De Equipo (Recall) de Device Recall GE Centricity PACSIW

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 It.

¿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
    64730
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0118-2014
  • Fecha de inicio del evento
    2012-06-15
  • Fecha de publicación del evento
    2013-10-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-06-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116875
  • 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
    Multiple issues were identified with the ge centricity pacs-iw system that could pose a safety risk to patients. these issues include: 1) with auto-fetch in use another patient's image may appear without user's intention. 2.A) in the case where dose administration time and image acquisition time fall on either side of midnight, the value will be under reported and close to zero for all pixe.
  • Acción
    GE Healthcare sent an IMPORTANT PRODUCT INFORMATION letter dated June 15, 2012 to direct accounts informing them of the Auto-Fetch functionality issue and advising them to discontinue the use of the Auto-Fetch feature and to change the system setting to not allow users privileges to use Auto-Fetch. Customers were requested to contact their Field Engineer or GE Service Representative with any questions or to call the GE Healthcare Remote Online Center Customer Care Center at 1-800-437-1171. GE Healthcare sent an URGENT MEDICAL DEVICE CORRECTION letter dated March 12, 2013 to all affected customers informing them of all three of the safety issues. The letter again adivsed customers to discontinue the use of the Auto-Fetch feature and to change the system setting to not allow users privileges to use Auto-Fetch. The letter further infomed customers that all three errors can be resolved through the installation of a new version of the software. Customers were requested to contact their Field Engineer or GE Service Representative with any questions or to call the GE Healthcare Remote Online Center Customer Care Center at 1-800-437-1171.

Device

Device Recall GE Centricity PACSIW
  • Modelo / Serial
    Software Versions: 3.7.1, 3.7.1.1, 3.7.2, 3.7.3.1, 3.7.3.3, 3.7.3.4, 3.7.3.5, 3.7.6.3, 3.7.3.7, and 3.7.3.8
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, District of Columbia, Puerto Rico, and the U.S. Virgin Islands. Internationally to Austria, Azerbaijan, Bahrain, Belgium, Bosnia, Brazil, Canada, Columbia, Egypt, France, Germany, Ghana, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Libya, Lithuania, Mexico, Netherlands, Nigeria, Palestine, Poland, Qatar, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, and Yemen. Center Recommended Depth - Consumers/User**
  • Descripción del producto
    Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images may only be interpreted using an FDA approved monitor that offers at least 5 M pixel resolution and meets other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians an assistants.
  • Manufacturer
    Ge Healthcare It

Manufacturer

Ge Healthcare It
  • Dirección del fabricante
    Ge Healthcare It, 540 W Northwest Hwy, Barrington IL 60010-3051
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA