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Recall Observatory FDA recall evidence

Device 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.

Z-0206-2013

October 05, 2012

Class II

Product summary

Firm
Philips Medical Systems (Cleveland), Inc.
Event
Event 63430
Status
Terminated
Classification
Class II
Quantity
11
Official record key
device-enforcement:Z-0206-2013

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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