—#113761

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.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K041577
Affected lot / code info: Serial # 317, 318, 319, 320,321,342, 343, 344,345, 346, 347

Why it was recalled

Philips Medical Systems Cleveland), Inc. is recalling Pinnacle3 Virtual Client Connection software version 3.1 due to an improper release and subsequent distribution.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems (Cleveland), Inc.
Address: 5520 Nobel Dr, Ste 125, Fitchburg, Wisconsin 53711-4948

Distribution

Distribution pattern: Nationwide distribution: USA including states of: ME, MI, NY, and WI.

Timeline

Recall initiated: 2012-10-05
Posted by FDA: 2012-11-05
Terminated: 2013-02-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #113761. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.