Events

Alerta De Seguridad para Digital Linear Accelerator

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

¿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
    2015-03-31
  • Fecha de publicación del evento
    2015-03-31
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150331.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
    Medical device safety alert: elekta digital linear accelerator it has come to our attention that medical device manufacturer, elekta, has identified an unserviceable batch of bolts used to install the counterbalance weight assembly on the gantry drum of elekta digital linear accelerator [serial numbers: 152807, 152943, 153060, 153255, 153300, 153348 - 153350, 153359, 153406, 153511, 153530 - 153532, 153534 - 153586, 153588 - 153620, 153622 - 153647, 153649 - 153670, 153672 - 153678, 153680, 153683 - 153685, 153691, 153696, 153699, 153702, 153710, 153712, 153713, 153715, 153717, 153723 - 153728, 153734] the defective bolts have the mark “of” on the head. if the bolts have a fault, the gantry drum is not stable. it can fall and cause fatal injuries to users. the manufacturer will replace all the defective bolts that have the mark “of” on the head. the manufacturer advises users not to use the digital linear accelerator until the bolts are checked by the manufacturer’s representative. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 31 march 2015.

Device

Digital Linear Accelerator
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Elekta Digital Linear Accelerator
  • Manufacturer
    Elekta

Manufacturer

Elekta
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    DH