Company:Philips Nuclear Medicine, Inc.,
Date of Enforcement Report:10/3/2007
Class:ll
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), Recall # Z-1212-2007
REASON
Incorrect Absolute Marking Coordinates when used with PQ-Series scanners due to a software malfunction.
RECALLING FIRM/MANUFACTURER
Philips Nuclear Medicine, Inc., Fitchburg, WI, by letter on August 21, 2007. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1,407 units
DISTRIBUTION
Nationwide and Canada
