Alerta De Seguridad para On-Board Imager

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
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • 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: varian medical systems on-board imager medical device manufacturer, varian medical systems, has issued a medical device safety alert concerning its on-board imager. the manufacturer has received three reports that the shaft of the type 01 elbow motor for exact arms used in the on-board imager [obi] device have failed due to belt over-tensioning. this over-tensioning would have taken place during servicing. this failure would allow the exact arm to swing freely with gravity. no injuries have been reported to-date. only type 01 elbow motors are subject to these potential failures. according to the manufacturer, potential injury from the kv source striking a patient is dependent upon the anatomic site being treated and the height of the couch. the risk is greatest when the obi x-ray source is extended or retracted while it is above the patient. a geometric analysis determined that when the couch is positioned for a pelvis treatment [e.G., prostate treatments], the head of the patient could be positioned within the arc travelled by the kv source. if the kv source were to strike the patient’s head or chin, a fracture injury is possible. pelvic treatments with couch vertical positions less than 10 centimeters below isocenter have the highest potential for injury. the manufacturer instructs all affected users not to extend or retract the kv source arm when it is above a patient until the manufacturer inspects the obi exact arms. users should ensure that the gantry is positioned so that the kv source is lateral to, or underneath, the patient-couch prior to extending or retracting the arm. according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 26 march 2014.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Varian Medical Systems On-Board Imager
  • Manufacturer