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 INC..

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
    77880
  • Event Risk Class
    II
  • Event Initiated Date
    2016-12-21
  • 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
    If a physical wedge for which the total field size limit perpendicular to the wedge direction is more than 10 cm larger than the field size limit in wedge direction is inserted in in-plane direction (as seen with collimator angle 0 degrees) then with very large fields perpendicular to wedge direction a part of the scattered fluence can become unmodulated by the wedge. this will result in profile "horns" close to the edge of the field.

Device

ONCENTRA EXTERNAL BEAM/ONCENTRA BRACHY 4.5
  • Model / Serial
    Model Catalog: 170.730 (Lot serial: Version 4.5.X)
  • Product Description
    ONCENTRA EXTERNAL BEAM/ONCENTRA BRACHY 4.5
  • Manufacturer
    ELEKTA INC.

Manufacturer

ELEKTA INC.
  • Manufacturer Address
    ATLANTA
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    HC