Events

Recall of PINNACLE THERAPY PLANNING SYSTEM - KIT

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
    28489
  • Event Risk Class
    II
  • Event Initiated Date
    2014-08-05
  • 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 the dose may be inconsistent with the density of a density-overriden roi (region of interest). the issue occurs under certain specific conditions where the user modifies a contour in a density-overridden roi (region of interest with density set to a specific value) in a computed plan dose is subsequently invalidated and the user may recompute the dose. in this case the density can be replaced by the ct number from the ct to density table when recomputed resulting in an incorrect dose and the monitor units (mu) may then be much higher than origianlly planned. the user may continue and save the plan with incorrect dose. when the plan is reopened the density is reported as the correct value but the dose remains incorrect based on the prior incorrect value for density.

Device

PINNACLE THERAPY PLANNING SYSTEM - KIT
  • Model / Serial
    Model Catalog: 453560453781 (Lot serial: >10 NUMBERS CONTACT MFG.)
  • Product Description
    PINNACLE THERAPY PLANNING SYSTEM - KIT
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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