Events

Recall of PINNACLE 3 RADIATION THERAPY PLANNING SYSTEM - SMARTARC MODULE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHILIPS ELECTRONICS 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
    53142
  • Event Risk Class
    II
  • Event Initiated Date
    2013-08-01
  • 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
    Under certain conditions in pinnacle 9 9.2 and 9.4 the customer can modify the geometry of a beam or change the parameters for a bolus and the software does not invalidate the control point dose. this occurs in two situations: - the customer sets the 'speed up collimator movements' field in the beam's eye view options window to yes sets the 'store control point dose' field in the control points window to yes computes dose for a beam that uses control points and then uses the collimator tool (shown at left) to adjust the collimator or jaw positions. - the customer sets the 'store control point dose' field in the control points window to yes computes dose on a beam that uses control points and bolus and then changes a parameter for a bolus that is applied to that beam.

Device

PINNACLE 3 RADIATION THERAPY PLANNING SYSTEM - SMARTARC MODULE
  • Model / Serial
    Model Catalog: 4535 604 46041 (Lot serial: N/A)
  • Product Description
    PINNACLE 3 RADIAION THERAPY PLANNING SYSTEM-SMARTARC MODULE
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC