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U.S. Department of Health and Human Services

Class 2 Device Recall Pinnacle3 Software Version 10.0

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  Class 2 Device Recall Pinnacle3 Software Version 10.0 see related information
Date Initiated by Firm April 23, 2015
Date Posted May 21, 2015
Recall Status1 Terminated 3 on October 05, 2016
Recall Number Z-1643-2015
Recall Event ID 71117
510(K)Number K041577  
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
Product Pinnacle3 Software Version 10.0, Model 459800200841.

Product Usage:
The Pinnacle 3 RTP software allows qualified medical professionals to enter patient data into the system, use that data to construct a plan for radiation therapy and evaluate the plan. Optionally, the qualified medical personnel may output the plan in an electronic or printed form for use by other systems in the delivery of treatment to a patient.
Code Information "System Code S/N"  1439NML05A, 1117FMM025, DC090775040, 1117FMM03J. 
Recalling Firm/
Manufacturer		 Philips Medical Systems, Inc.
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Technical Support
978-687-1501
Manufacturer Reason
for Recall		 A problem (the dose computed in planning mode is calculated incorrectly ) has been detected in the Philips Pinnacle3 software version 10.0 that, if it were to re-occur, could pose a risk for patients or users. Specifically, the dose engine is being passed the wrong snout position. The snout position is used to determine the penumbra of the beam which includes the calculation of the source si
FDA Determined
Cause 2		 Software design
Action Philips Healthcare sent a "Field Safety Notification PROST-T-300-01-06" letter dated 20 April 2015 to their customers. The letter described the Problem Description, Hazard Involved, How to Identify Affected Products, Action to be Taken by Customer / User, Actions Planned by Philips and Further Information and Support (Contact Philips Customer Care Solutions Center at 1-800-722-9377).
Quantity in Commerce 4
Distribution US Nationwide Distribution in the states of MO, FL, OH
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = ADAC LABORATORIES
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