Events

Alerta De Seguridad para Optical Guidance Platform (OGP) with Frameless Array Module HZ1/HZ6

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

¿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
    2012-03-19
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120319.html
  • 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
    Field safety notice: varian optical guidance platform (ogp) with frameless array module hz1/hz6 it comes to our attention that an issue has been identified with the varian optical guidance platform (ogp), v 2.6 and 2.6.1 of a possible infrared light reflection resulting in an inability to calibrate the ogp or track the optical guidance tool (accessory) during use. as a result, the ogp may be unable to track the positioning tool or in one reported case, display an improper correction vector. the risk associated with this error is the offset at isocentre of the beam by 2 mm, which can result in severe injury, death or permanent total disability. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Optical Guidance Platform (OGP) with Frameless Array Module HZ1/HZ6
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Varian Optical Guidance Platform (OGP) with Frameless Array Module HZ1/HZ6
  • Manufacturer
    Varian Medical Systems, Inc.

Manufacturer

Varian Medical Systems, Inc.