Events

Safety Alert for XVI R4.0 to R4.2.1, R4.5.0, R4.5.1 and R5.0.0 to R5.0.1

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Elekta.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2014-07-22
  • Event Date Posted
    2014-07-22
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140722.html
  • Notes / Alerts
    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.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: elekta xvi r4.0 to r4.2.1, r4.5.0, r4.5.1 and r5.0.0 to r5.0.1 the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice (fsn) concerning xvi r4.0 to r4.2.1, r4.5.0, r4.5.1 and r5.0.0 to r5.0.1, manufactured by elekta. the user does an online volumeview acquisition and registration. the user accepts the registration and the “table move assistant” dialog box appears. two different scenarios mentioned in the fsn can result from the same error. this issue may cause clinical mistreatment and collision risk resulting in fatal injury to the patient. the manufacturer advises users of the followings: monitor the “relative actual” and “absolute actual” columns of the “table move assistant” dialog box, if these values are blank do not press the table asu buttons on the function keypad (fkp); or if users see a movement larger than the “relative actual” and the “absolute actual” does not update, they should follow the procedure mentioned in the fsn to correct the error. when doing volumeview acquisitions with an external bld attached, users should make sure that the stop angle of the volumeview parameters is in the lower half of the gantry rotation. this decreases the risk of a collision with the patient. a later software release of xvi will be supplied which gives a solution to this problem. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con433868 if you are in possession of the product, please contact your supplier for necessary actions. posted on 22 jul 2014.

Device

XVI R4.0 to R4.2.1, R4.5.0, R4.5.1 and R5.0.0 to R5.0.1
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Elekta XVI R4.0 to R4.2.1, R4.5.0, R4.5.1 and R5.0.0 to R5.0.1
  • Manufacturer
    Elekta

Manufacturer

Elekta
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    DH