Events

Safety Alert for Pinnacle3 Radiation Treatment Planning System

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Philips Healthcare.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2014-08-08
  • Event Date Posted
    2014-08-08
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140808.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: philips healthcare pinnacle3 radiation treatment planning system medical device manufacturer, philips healthcare, has issued a field safety notice (fsn) concerning its pinnacle3 radiation treatment planning system with software version 9 0, 9 2 9 4, and 9 6. 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 originally planned. the user may continue, and save the plan with incorrect dose. when reopening the plan, the density is reported as the correct value but the dose remains incorrect based on the prior incorrect value for density. this issue could create an incorrect mu calculation, resulting in an incorrect dose to the target or other structures. if the situation is noticed prior to completion of the treatment, the incorrect beam could be corrected to give the correct total dose.¬ the manufacturer will upgrade all the affected units to version 9.8 and it recommends users to always use version 9.8 or above for patient planning. if users do not have version 9.8 installed, they should contact local representative. furthermore, the fsn should be placed in instructions for use until otherwise notified. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 8 aug 2014.

Device

Pinnacle3 Radiation Treatment Planning System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Philips Healthcare Pinnacle3 Radiation Treatment Planning System
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DH