Events

Retiro De Equipo (Recall) de Device Recall IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR)

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 AGFA Corp..

¿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
    60165
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0212-2012
  • Fecha de inicio del evento
    2011-06-06
  • Fecha de publicación del evento
    2011-11-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-05-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104633
  • 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
    Incorrect entries in mapping files could lead to inaccurate measurement display in adult and pediatric echo reports when using the impax cv echo measurement import via optical character recognition (ocr).
  • Acción
    The firm, AGFA HealthCare" sent an 'URGENT FIELD SAFETY NOTICE" dated May 27, 2011 via FED-EX by June 6, 2011 to all customers using the affected product. The letter describes the product, problem and actions to be taken. The customers were instructed to distribute this information within their facility to all those who need to be aware and to complete and return the attached FEEDBACK FORM via fax to 864-421-1668 or email to debbie.norris@agfa.com. AGFA will provide software corrections to all affected sites and will contact the customers to schedule the analysis and provide any corrections if required. If you have any questions about this matter, please contact your local Agfa HealthCare Service at 877-777-2432.

Device

Device Recall IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR)
  • Modelo / Serial
    Software Versions - All DICOMStore Version 2.04.44 and earlier
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: AK, AZ, CA, CO, DC, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, and WV; and country of: Canada.
  • Descripción del producto
    IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) || The IMPAX Cardiovascular suite is a cardiovascular Information system providing image archiving and image display and modality study-specific structured reporting.
  • Manufacturer
    AGFA Corp.

Manufacturer

AGFA Corp.
  • Dirección del fabricante
    AGFA Corp., 10 S Academy St, Greenville SC 29601-2632
  • Source
    USFDA