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U.S. Department of Health and Human Services

Enforcement Report - Week of November 14, 2012
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Event Detail

Event ID 63430
Product Type Devices
Status Ongoing
Recalling Firm Philips Medical Systems (Cleveland), Inc.
City Fitchburg
State WI
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-05
Initial Firm Notification of
Consignee or Public		 Letter
Distribution Pattern Nationwide distribution: USA including states of: ME, MI, NY, and WI.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Serial # 317, 318, 319, 320,321,342, 343, 344,345, 346, 347 Class II Philips Medical Systems Cleveland), Inc. is recalling Pinnacle3 Virtual Client Connection software version 3.1 due to an improper release and subsequent distribution. 11 Z-0206-2013
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