Recall Z-1212-2007 ยท MUJ System, Planning, Radiation Therapy Treatment
Philips Nuclear Medicine, Inc.
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 c
| Date | Sep 25, 2007 (initiated Aug 21, 2007) |
| Status | Terminated |
| Reason | Incorrect Absolute Marking Coordinates when used with PQ-Series scanners due to a software malfunction |
| Root cause | Other |
| 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. |
| Quantity | 1,407 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041577 | PINNACLE3 RADIATION THERAPY PLANNING SYSTEM Adac Laboratories, Jun 25, 2004 |