FDA Device recall Z-1312-2014

Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0

FDA Device
Class II
terminated
Published 2014-04-09

On 2014-04-09 the FDA classified a Class II recall of Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0 by Philips Medical Systems Cleveland, citing philips Medical Systems have recently determined that a software nonconformance can cause incorrect beam geometry. This issue affects Pinnacle3 Radiation Therapy Planning (RTP) Sy….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1312-2014
Classification	Class II
Status	terminated
Initiated	2014-02-11
Published	2014-04-09
Last updated	2026-09-13 11:53 UTC
Company	Philips Medical Systems Cleveland
Distribution	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, WV

Product

Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0.

Reason

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.

Identifiers

code_info	System Code Serial Number DC040898989 DC120785335 DC040801181 DC020893846 DC020893848 DC030936872 DC030938113 D… 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

code_info

System Code Serial Number DC040898989 DC120785335 DC040801181 DC020893846 DC020893848 DC030936872 DC030938113 D…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1312-2014%22

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