Events

Recall of 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 (Cleveland), 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
    63430
  • Event Risk Class
    Class 2
  • Event Number
    Z-0206-2013
  • Event Initiated Date
    2012-10-05
  • Event Date Posted
    2012-11-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113761
  • 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, nuclear magnetic resonance imaging - Product Code IYE
  • Reason
    Philips medical systems cleveland), inc. is recalling pinnacle3 virtual client connection software version 3.1 due to an improper release and subsequent distribution.
  • Action
    The firm, Philips Healthcare, sent a "Customer Information Letter" dated 2012 Oct 05. The letter listed the affected products, problem description, how to identify affected products, advise on actions by customer / user, actions planned by Philips and further information and support. The letter stated that no action is needed on the part of the customer. The field service engineer will be scheduling a site visit to complete the replacement. Philips Healthcare will be delivering the correct VCC kit. For customers in North America if you need any further information or support concerning this issue, please contact our Customer Care Solutions Center at 1-800-722-9377. Select option 5 for "All Imaging Systems". Enter your site ID # (If you do not have a site ID#, simply pause for a moment.). Select option 5 for "Nuclear Medicine" and finally select option 3 for "Pinnacle" support.

Device

Pinnacle3 Radiation Therapy Planning System
  • Model / Serial
    Serial # 317, 318, 319, 320,321,342, 343, 344,345, 346, 347
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: ME, MI, NY, and WI.
  • Product Description
    Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. || Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. Pinnacle3 Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The system is capable of operating in both the forward planning and inverse planning modes. The device is indicated for use in patients deemed to be acceptable candidates for radiation treatment in the judgment of the clinician responsible for patient care. Plans generated using this system are used in the determination of the course of a patient's radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel.
  • Manufacturer
    Philips Medical Systems (Cleveland), Inc.

Manufacturer

Philips Medical Systems (Cleveland), Inc.
  • Manufacturer Address
    Philips Medical Systems (Cleveland), Inc., 5520 Nobel Dr Ste 125, Fitchburg WI 53711-4948
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA