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
    32817
  • Event Risk Class
    II
  • Event Initiated Date
    2011-11-17
  • 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
    Philips has become aware that when the user changes the machine for step and shoot beams from a fixed jaw to a variable jaw machine the jaws may change from symmetry to asymmetry to duplicate the original beam but the jaw symmetry yes/no option remains set to yes. when exported via dicom rt the multileaf collimeter (mlc) and jaw positions agree with the pinnacle plan. however because the jaw symmetry flag is set to yes the record and verify (r&v) system may force the jaws to be symmetric thereby re-positioning the beam. the resulting beam on the r&v side does not match the beam in pinnacle.

Device

PINNACLE 3 RADIATION THERAPY PLANNING SYSTEM - SMARTARC MODULE
  • Model / Serial
    Model Catalog: 4535 604 46041 (Lot serial: >15 S/N CONTACT MFR)
  • Product Description
    PINNACLE 3 RADIATION THERAPY PLANNING SYSTEM-SMARTARC MODULE
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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