Events

Alerta De Seguridad para FrameArray Module HZ7 and Floorstand HZ5

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Varian 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
    2011-10-07
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111007.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
    Urgent field safety notice: varian framearray module hz7 and floorstand hz5 medical device manufacturer, varian medical systems, has issued an urgent field safety notice concerning head ring posts used by both the framearray module (of the optical guidance platform) hz7 and floorstand hz5, where the head ring posts may be damaged due to excessive mechanical stress, resulting in possible failure during usage. this could result in the movement of the headring relative to the patient’s anatomy. according to the supplier, the affected devices have been distributed in hong kong. varian is sending a notification letter to affected users to remind them to inspect their head ring posts and verify that they are using the current design and that it is labeled with the part number 970.284. if the posts are not labeled 970.284, customers should discontinue use and contact varian service for replacement. varian will also arrange an inspection of all head ring posts and replace affected units.

Device

FrameArray Module HZ7 and Floorstand HZ5
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Varian FrameArray Module HZ7 and Floorstand HZ5
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems