Z-1212-2007

The Pinnacle3 Radiation Therapy Planning (RTP) system and its associated software; composed of several...

Name: Z-1212-2007 The Pinnacle3 Radiation Therapy Planning (RTP) system and its associated software; composed of several...
Creator: Philips Nuclear Medicine, Inc.
Published: 2007-08-21
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2007-08-21 / Terminated / root cause: software

FDA source

Philips Nuclear Medicine, Inc. began a recall of The Pinnacle3 Radiation Therapy Planning (RTP) system and its associated software; composed of several modules including the core Pinnacle3 functionality... on 2007-08-21. The reason FDA records is "Incorrect Absolute Marking Coordinates when used with PQ-Series scanners due to a software malfunction". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1212-2007
Status: Terminated
Initiated: 2007-08-21
Posted: 2007-09-25
Terminated: 2011-12-17
Recalling firm: Philips North America LLC
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)
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Incorrect Absolute Marking Coordinates when used with PQ-Series scanners due to a software malfunction
Root cause tag: software
FDA 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 in commerce: 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
Product codes and lots: 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

Product code MUJ

K041577Class IIPinnacle3 Radiation Therapy Planning SystemAdac Laboratories / cleared 2004-06-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)