Events

Retiro De Equipo (Recall) de Device Recall Horizon Medical Imaging system.

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 Mckesson Medical Imaging Group.

¿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
    62567
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2238-2012
  • Fecha de inicio del evento
    2012-05-29
  • Fecha de publicación del evento
    2012-08-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-09-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111058
  • 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
    There is a potential to save reports in radreport with an incorrect final status.
  • Acción
    McKesson sent an Urgent Field Safety Notice letter dated May 29, 2012 to all affected consignees. The letter identified the affected product, circumstances under which the issue occurs and immediate actions to be taken. Customers were advised to notify the Customer Support department that they have read and understood this Advisory Notice at 1-800-663-2533. For questions contact the Support Manager at the Customer Support department.

Device

Device Recall Horizon Medical Imaging system.
  • Modelo / Serial
    Horizon Medical Imaging (HMI) versions 11.5, 11.5.1, 11.5.2, 11.6 and 11.7.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - U.S. Nationwide and the countries of: Canada, France, Ireland and United Kingdom.
  • Descripción del producto
    Horizon Medical Imaging system. || Product Usage: || Horizon Medical Imaging is a medical image and information management application that is intended to receive, transmit store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical image systems. The medical modalities of these medical imaging systems include, but are not limited to, all modalities supported by ACR/NEMA DICOM 3.0 (specifically including mammographic images). Horizon Medical Imaging is intended to function with a variety of storage systems and printers via DICOM and other computer industry standard interfaces and protocols. Horizon Medical Imaging is indicated for use by trained medical professionals including, but not limited to, radiologist, physicians, and medical technologists. Horizon Medical Imaging is also indicated for use in soft copy diagnostic interpretation of medical images and video by physicians trained in such practice (specifically including soft copy diagnostic interpretation of mammographic images).
  • Manufacturer
    Mckesson Medical Imaging Group

Manufacturer

Mckesson Medical Imaging Group
  • Dirección del fabricante
    Mckesson Medical Imaging Group, 10711 Cambie Rdsuite 130, Richmond Canada British Columbia
  • Source
    USFDA