Events

Recall of SHAREPLAN (RADIATION TREATMENT PLANNING SOFTWARE)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by RAYSEARCH LABORATORIES AB (PUBL).

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
    50095
  • Event Risk Class
    III
  • Event Initiated Date
    2011-06-01
  • 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
    Treatment plans with differing fraction sizes from certain versions of tomotherapy hi*art are not recognized as having multiple fraction groups. it is also assumed that curves calibration depth and output factor depth all have the same offset.^.

Device

SHAREPLAN (RADIATION TREATMENT PLANNING SOFTWARE)

Manufacturer

RAYSEARCH LABORATORIES AB (PUBL)