Alerta De Seguridad para Millenium VG Variable Geometry Dual Detector Camera-Hawkeye, Hawkeye 4, Infinia Dual Detector Gamma Camera, Discovery NM/CT 670 and NM 630 System

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por GE Medical Systems.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2014-10-10
  • Fecha de publicación del evento
    2014-10-10
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: ge millenium vg variable geometry dual detector camera-hawkeye, hawkeye 4, infinia dual detector gamma camera, discovery nm/ct 670 and nm 630 system health canada has issued a medical device safety alert concerning millenium vg variable geometry dual detector camera-hawkeye, hawkeye 4, infinia dual detector gamma camera, discovery nm/ct 670 and nm 630 system, manufactured by ge medical systems. according to the safety alert, the manufacturer performed a field action on ge healthcare nuclear medicine system due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. as part of this field action, the manufacturer updated the preventative maintenance procedure and schedule and added an additional preventative maintenance check for loose fasteners. for details, please visit the following health canada website: http://www.Healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2014/41685r-eng.Php if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 10 october 2014.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: GE Millenium VG Variable Geometry Dual Detector Camera-Hawkeye, Hawkeye 4, Infinia Dual Detector Gamma Camera, Discovery NM/CT 670 and NM 630 System
  • Manufacturer

Manufacturer