Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0.
Medical device recall Z-1312-2014. Published in FDA’s Enforcement Report on Apr 9, 2014.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 9, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 49 states named in where it went
- 1016 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Philips Medical Systems have recently determined that a software nonconformance can cause incorrect beam geometry. This issue affects Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0 manufactured from 09/29/09 to 12/01/2013.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0.
1016, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
System Code Serial Number DC040898989 DC120785335 DC040801181 DC020893846 DC020893848 DC030936872 DC030938113 DC030938457 DC070948475 DC070948476 DC100956827 DC120961879 DC011064963 DC090775316 DC021070642 DC061086404 DC091095147…
Every code shown here, 1,993 characters
System Code Serial Number DC040898989 DC120785335 DC040801181 DC020893846 DC020893848 DC030936872 DC030938113 DC030938457 DC070948475 DC070948476 DC100956827 DC120961879 DC011064963 DC090775316 DC021070642 DC061086404 DC091095147 DC060767368 DC010887574 DC110782289 DC120787279 DC061132521 DC061132519 DC081138659 DC081138643 DC081139521 DC081139520 1755367 DC080815579 DC070813153 1685358 1134FMM0UW DC090777023 15 DC030936391 ¿15 1708792 1708999 0841BD200F 3/1133FMM0C2 DC110781164 DC060764615 DC060764372 0908QAC00B 0926QAD063 0925QAD076 1666738 0925QAD09E 1029QAD07C 1678826 1684436 0926QAC016 1029QAD06F 0926QAC01C 1714167 1049FMMOGP 1113FMMORB 1113FMMORL 1688542 1688675 1691300 1691303 1694794 1696697 1699759 1699760 1700756 1699761 1699762 1701404 1701389 1715642 1704521 1708407 1709924 1710887 36 1734189 1721212 1723472 1723474 1722542 1730747 1722550 1723491 1730850 1730848 1730746 1737467 1730852 1732235 1732294 1734761 1735978 1736604 1737853 1734675 1738571 1737480 1741347 1746235 1740700 1747900 1745450 1751925 1753082 1753079 1753777 1759510 1759731 1757173 1762113 1665097 1659082 1657556 1659148 1655919 1657364 1657112 1657781 1657783 1657782 1659128 1659129 1685591 1685365 1685354 1685589 1700520 1685685 1685608 1685590 1685604 1702674 1718378 DC051081744 1685357 1700519 1700649 1707577 1706939 1707985 1724442 1724444 58 1746975 1734748 1 5 12 2 3 1753818 1754275 1759838 10 DC090775322 DC090776030 DC120787277 DC020893856 DC070811143 DC070812912 DC050802592 DC050802591 DC050802954 DC030895175 DC050802595 DC121008240 DC070899024 DC030895174 DC030895490 DC020893296 DC090818684 DC090819874 DC030936392 DC090816435 DC120830822 DC120830821 21DC041125223 DC030937243 DC040939540 DC040941365 DC050943690 DC100820417 1661883 1657952 1658310 1657202 DC050802593 70 DC100955993 1663161 1662399 1662400 80 DC031121325 1663005 1675295 1675300 1675298 1675304 1672877 1675302 1676359 1702701 1685603 1685516 1685512 DC040941365 1685511 1702616 1702222 1702214 DC060945180…
FDA’s list runs to 5,102 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - USA including US: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and Internationally to AUSTRALIA, AUSTRIA. BELGIUM, CANDA, CHINA, DENMARK, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, IRELAND, ITALY, JAPAN, LUXEMBOURG, MALAYSIA, MEXICO, MONTENEGRO, NETHERLANDS, NEW ZEALAND, OMAN, RUSSIA, SOUTH ARICA, SOUTH KOREA. SPAIN,. SWITZERLAND, TAIWAN, THAILAND, TURKEY, EMIRATES, UNITED KINGDOM. .
The states and territories these words name
49 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 11, 2014.
- FDA classified it on Mar 31, 2014.
- FDA’s Enforcement Report published it on Apr 9, 2014.
- FDA terminated it on Nov 21, 2014.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips Medical Systems (Cleveland), Inc., of Fitchburg, WI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 5,102 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.