The 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)
This recall has been terminated (originally issued September 25, 2007).
- Company
- Philips Nuclear Medicine, Inc.
- Recall Initiated
- August 21, 2007
- Posted
- September 25, 2007
- Terminated
- December 17, 2011
- Recall Number
- Z-1212-2007
- Quantity
- 1,407
- Firm Location
- Fitchburg, WI
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect Absolute Marking Coordinates when used with PQ-Series scanners due to a software malfunction
Distribution
Worldwide 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
Lot / Code Info
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
Root Cause
Other
Action Taken
All 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.