Recall Z-0206-2013— Philips Medical Systems (Cleveland), Inc.

Name: FDA recall Z-0206-2013
Creator: U.S. Food and Drug Administration
Published: 2012-10-05

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland), Inc., initiated 2012-10-05, terminated 2013-02-21. It names one FDA 510(k) clearance: K041577. 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.. Reason: Philips Medical Systems Cleveland), Inc. is recalling Pinnacle3 Virtual Client Connection software version 3.1 due to an improper release and subsequent distribution..

Recalling firm: Philips Medical Systems (Cleveland), Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-10-05
Terminated: 2013-02-21
Firm location: Fitchburg, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K041577 — PINNACLE3 RADIATION THERAPY PLANNING SYSTEMAdac Laboratories·cleared 2004-06-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.