Events

Recall of Pinnacle3 Software Version 10.0

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

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
    71117
  • Event Risk Class
    Class 2
  • Event Number
    Z-1643-2015
  • Event Initiated Date
    2015-04-23
  • Event Date Posted
    2015-05-21
  • 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=136154
  • 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
    System,planning,radiation therapy treatment - Product Code MUJ
  • Reason
    A problem (the dose computed in planning mode is calculated incorrectly ) has been detected in the philips pinnacle3 software version 10.0 that, if it were to re-occur, could pose a risk for patients or users. specifically, the dose engine is being passed the wrong snout position. the snout position is used to determine the penumbra of the beam which includes the calculation of the source si.
  • Action
    Philips Healthcare sent a "Field Safety Notification PROST-T-300-01-06" letter dated 20 April 2015 to their customers. The letter described the 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

Pinnacle3 Software Version 10.0
  • Model / Serial
    "System Code S/N"  1439NML05A, 1117FMM025, DC090775040, 1117FMM03J.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of MO, FL, OH
  • Product Description
    Pinnacle3 Software Version 10.0, Model 459800200841. || Product Usage: || The Pinnacle 3 RTP software allows qualified medical professionals to enter patient data into the system, use that data to construct a plan for radiation therapy and evaluate the plan. Optionally, the qualified medical personnel may output the plan in an electronic or printed form for use by other systems in the delivery of treatment to a patient.
  • Manufacturer
    Philips Medical Systems, Inc.

Manufacturer

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