Events

Safety Alert for Pinnacle3 software

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
    2013-05-08
  • Event Date Posted
    2013-05-08
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130508c.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 pinnacle3 software medical device manufacturer, philips healthcare issued a field safety notice concerning all pinnacle3 software with versions 9, 9.2, and 9.4. a problem has been detected in the philips pinnacle3 software that, if it were to re-occur, could affect the performance of the equipment. under certain conditions in pinnacle3 9, 9.2, and 9.4, users can modify the geometry of a beam or change the parameters for a bolus and the software does not invalidate the control point dose. philips healthcare is distributing an addendum to the pinnacle3 instructions for use (ifu) which describes how to explicitly invalidate control point dose in this situation. the underlying issue is corrected in pinnacle3 9.6. the manufacturer recommends customers to review the information contained in the notice including the ifu addendum with all members of the staff who need to be aware of their contents and retain a copy of the addendum with the pinnacle3 9, 9.2, and 9.4 ifu. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 08 may 2013.

Device

Pinnacle3 software
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Philips Pinnacle3 software
  • Manufacturer
    Philips Healthcare

Manufacturer

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