Events

Retiro De Equipo (Recall) de Device Recall Imagecast PACS

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
    64740
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0773-2014
  • Fecha de inicio del evento
    2011-03-04
  • Fecha de publicación del evento
    2014-01-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-05-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116903
  • 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
    In imagecast pacs versions prior to 3.6.51.01, the estimated magnification factor (0018,1114) was not accounted for. these versions of imagecast pacs look for values to be present in the following tags to calculate a measurement from pixels to millimeters (mm): (0020,0030) pixel spacing and, (0018,1164) imager pixel spacing. because the estimated magnification factor is not used, distance meas.
  • Acción
    Important Product Information Letters dated March 4, 2011 were sent to all customers that received the defective software. The letters advised customers to upgrade their PACS software version to Imagecast 3.6. The software upgrade can be requested from GE Support via the eService portal or by telephone at 1-800-437-1171. If the customer elects to not upgrade the software, instructions were provided for a new system calibration procedure.

Device

Device Recall Imagecast PACS
  • Modelo / Serial
    Imagecast PACS versions prior to 3.6.51.01
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution: US including states of: AL, AZ, CT, FL, GA, IA, IN, LA, MA, MI, MN, MO, NC, NH, NJ, NY, OH, PA, TX, VA, WI, WV + District of Columbia.
  • Descripción del producto
    Imagecast PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image and interpretations. Mammongraphic may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by the FDA.
  • 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