Recalling Firm / Manufacturer

Philips Nuclear Medicine, Inc.

Product

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)

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

Reason of Recall

Incorrect Absolute Marking Coordinates when used with PQ-Series scanners due to a software malfunction

Date Recall Initiated

August 21, 2007

Action

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. Firm Initiated recall is ongoing.

Contact

Source of Information

U.S. FDA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.