Philips Medical Systems (Cleveland), Inc.: Medical Device Recall in 2012 - (Recall #: Z-0206-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 5, 2012

Date Posted: November 14, 2012

Recall Number: Z-0206-2013

Event ID: 63430

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.

Status: Terminated

Product Quantity: 11

Code Information:

Serial # 317, 318, 319, 320,321,342, 343, 344,345, 346, 347

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated