Class 2 Device Recall Pinnacle3 Radiation Therapy Planning System

• Date Initiated by Firm: October 05, 2012
• Date Posted: November 05, 2012
• Recall Status: Terminated on February 21, 2013
• Recall Number: Z-0206-2013
• Recall Event ID: 63430
• 510(K)Number: K041577
• Product Classification: System, nuclear magnetic resonance imaging - Product Code IYE
• Product: 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.
• Code Information: Serial # 317, 318, 319, 320,321,342, 343, 344,345, 346, 347
• Recalling Firm/ Manufacturer: Philips Medical Systems (Cleveland), Inc.; 5520 Nobel Dr Ste 125; Fitchburg WI 53711-4948
• For Additional Information Contact: 608-298-6901
• Manufacturer Reason for Recall: Philips Medical Systems Cleveland), Inc. is recalling Pinnacle3 Virtual Client Connection software version 3.1 due to an improper release and subsequent distribution.
• FDA Determined Cause: Process control
• 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.
• Quantity in Commerce: 11
• Distribution: Nationwide distribution: USA including states of: ME, MI, NY, and WI.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IYE and Original Applicant = ADAC LABORATORIES