Events

Recall of ONCENTRA EXTERNAL BEAM/ONCENTRA BRACHY 4.5

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ELEKTA LTD..

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
    77039
  • Event Risk Class
    II
  • Event Initiated Date
    2017-08-10
  • 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
    The issue is caused by the measured source paths for the following applicators: ring applicator sets ring ct/mr applicator sets interstitial ct/mr rings vienna ct/mr rings and advanced gynecological applicator - venezia with lunar-shaped ovoids which have a source step size of 2.5 mm for the microselectron afterloader. if you use such an applicator model to create a plan while the default step size of the afterloader is 5.0 the step size in the ring or lunar-shaped ovoids will be incorrect. they will be shown as 2.5 mm while the afterloader will deliver at 5.0 mm if the error is not detected during plan approval.

Device

ONCENTRA EXTERNAL BEAM/ONCENTRA BRACHY 4.5
  • Model / Serial
    Model Catalog: 170.730 (Lot serial: Version 4.5.2); Model Catalog: 170.730 (Lot serial: Version 4.5.1); Model Catalog: 170.730 (Lot serial: Version 4.5)
  • Product Description
    ONCENTRA EXTERNAL BEAM/ONCENTRA BRACHY 4.5
  • Manufacturer
    ELEKTA LTD.

Manufacturer

ELEKTA LTD.
  • Manufacturer Address
    MONTREAL
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    HC