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U.S. Department of Health and Human Services

Class 2 Device Recall The Pinnacle3 Radiation Therapy Planning System

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 Class 2 Device Recall The Pinnacle3 Radiation Therapy Planning Systemsee related information
Date Initiated by FirmAugust 21, 2007
Date PostedSeptember 25, 2007
Recall Status1 Terminated 3 on December 17, 2011
Recall NumberZ-1212-2007
Recall Event ID 39420
510(K)NumberK041577 
Product Classification Radiation Therapy Planning System - Product Code MUJ
ProductThe Pinnacle3 Radiation Therapy Planning (RTP) system and its associated software; composed of several modules including the core Pinnacle3 functionality, Syntegra (TM), P3IMRT, P3MD and AcQSim3 (TM). The Pinnacle3 RTP system is composed of a Sun UNIX workstation (or UNIX-complaint computer) running the Solaris operating system and software, and a UNIX terminal emulation package on a personal computer, which allows the user to enter patient data into the system, use that data to construct a plan for radiation therapy, and evaluate the plan- Philips Medical Systems-Model #9200-0652A-ENG, 9200-0700A-ENG, 9200-0700B-ENG, 9200-0700C-ENG (with software versions 7.6C, 8.0d and 8.0h)
Code Information Pinnacle3 Version 7.6c Software Kit Model #9200-0652A-ENG;Pinnacle3 Version 8.0d Software Kit Model #9200-0700A-ENG;Pinnacle3 Version 8.0d p 1 Software Kit Model #9200-0700B-ENG;Pinnacle3 Version 8.0h Software Kit Model #9200-0700C-ENG 
Recalling Firm/
Manufacturer		 Philips Nuclear Medicine, Inc.
5520 Nobel Dr Ste 125
Fitchburg WI 53711-4948
For Additional Information Contact
800-722-9377 Ext. 553
Manufacturer Reason
for Recall		Incorrect Absolute Marking Coordinates when used with PQ-Series scanners due to a software malfunction
FDA Determined
Cause 2		Other
ActionAll customers will receive an August 21, 2007, Customer Advisory Notification letter notifying them of the issue and the steps required to avoid the issue. Return receipts will be tracked. This is a short-term fix, a long term software fix will be issued shortly by the firm.
Quantity in Commerce1,407
DistributionWorldwide Distribution; USA including states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, and WI and Country of CANADA
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MUJ
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