Events

Recall of FLEXITRON BRACHYTHERAPY REMOTE AFTERLOADING SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by NUCLETRON B.V. (A WHOLLY OWNED SUBSIDIARY OF ELEKTA AB).

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    43340
  • Event Risk Class
    II
  • Event Initiated Date
    2011-06-22
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    In the service mode the "source alignment procedure" can be started with the door physically open as well as with the doorswitch on linac. this could potentially expose the operator to radiation.

Device

FLEXITRON BRACHYTHERAPY REMOTE AFTERLOADING SYSTEM

Manufacturer

NUCLETRON B.V. (A WHOLLY OWNED SUBSIDIARY OF ELEKTA AB)
  • Manufacturer Address
    VEENENDAAL
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    HC