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 (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
    60549
  • Event Risk Class
    Class 2
  • Event Number
    Z-0594-2012
  • Event Initiated Date
    2011-11-18
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105776
  • 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
    Phillips medical systems have recently determined that a software (pinnacle3 software version 9.0) nonconformance can cause incorrect beam geometry.
  • Action
    Consignees were sent on 11/18/11 a Philips "Urgent Medical Device Correction" letter dated 2011 Nov 16. The letter identified the affected product and described the Problem, Hazard Involved, How to Identify Affected Products, Action to be Taken by Customer/User, Actions Planned by Philips and Further information and Support. If customers observed the issue, they were to manually make the suggested change. In addition, customers were to place the letter in the Instructions for Use until otherwise notified. The firm will deliver 9.2 software release free of charge. Customers in North America are to contact Customer Care Solutions Center at 1-800-722-9377, if they have questions or need support concerning the recall.

Device

Device Recall Pinnacle3 Radiation Therapy Planning System
  • Model / Serial
    System Code # 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446111 453560446111 453560446041 453560446101 453560446041 453560446101 453560446041 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446041 453560446041 453560446041 453560446101 453560446101 453560446041 453560446101 453560446041 453560446111 453560446041 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446051 453560446041 453560446141 453560446141 453560446041 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446041 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446181 453560446181 453560446101 453560446041 453560446061 453560446041 453560446061 453560446061 453560446041 453560446041 453560446041 453560446201 453560446041 453560446041 453560446041 453560446041 453560446041
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV, and countries of AUSTRALIA, AUSTRIA, BELGIUM, CHINA, DENMARK, FRANCE, GERMANY, HONG KONG, ITALY, JAPAN, MALAYSIA, MONTENEGRO, NETHERLANDS, NEW ZEALAND, OMAN, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED KINGDOM, and CANADA.
  • Product Description
    Pinnacle3 Radiation Therapy Planning System, software version 9.0. || Model # Description || 453560446041 Pinnacle3 version 9.0 English || 453560446051 Pinnacle3 version 9.0 Simplified Chinese || 453560446061 Pinnacle3 version 9.0 Traditional Chinese || 453560446091 Pinnacle3 version 9.0 Dutch || 453560446101 Pinnacle3 version 9.0 French || 453560446111 Pinnacle3 version 9.0 German || 453560446141 Pinnacle3 version 9.0 Italian || 453560446161 Pinnacle3 version 9.0 Japanese || 453560446181 Pinnacle3 version 9.0 Spanish || 453560446201 Pinnacle3 version 9.0 Turkish || Intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes.
  • 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