Events

Recall of Device Recall PINNACLE3 RADIATION THERAPY PLANNING SYSTEM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems.

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
    73023
  • Event Risk Class
    Class 2
  • Event Number
    Z-0745-2016
  • Event Initiated Date
    2016-01-08
  • Event Date Posted
    2016-02-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142775
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Accelerator, linear, medical - Product Code IYE
  • Reason
    In ds/us proton planning, there is a correction factor used internally to the dose engine that is calculating improperly in some cases. this can result in an incorrect dose calculation.
  • Action
    Philips sent an "Urgent Medical Device Correction" letter dated 16-DEC-2015 to affected customers. The letter described the Affected Products, Problem Description, Hazard Involved, How to Identify Affected Products, Action to be Taken by Customer / User, Actions Planned by Philips and Further Information and Support (contact Philips Customer Care Solutions Center at 1-800-722-9377 ).

Device

Device Recall PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
  • Model / Serial
    Software Version 10.0.0 and 14.0.0
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US: Nationwide Distribution in the states of FL, OH, and MO.
  • Product Description
    DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Manufacturer Address
    Philips Medical Systems, 3000 Minuteman Rd, Andover MA 01810-1032
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA