PINNACLE3 Radiation Therapy Planning System

• • Ongoing Z-2570-2025 FDA Class II ·initiated 5 Aug 2025 ·on shared 510(k) K041577

  Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.

• • Terminated Z-1643-2015 FDA Class II ·initiated 23 Apr 2015 ·on shared 510(k) K041577

  A problem (the dose computed in planning mode is calculated incorrectly ) has been detected in the Philips Pinnacle3 software version 10.0 that, if it were to re-occur, could pose a risk for patients or users. Specifically, the dose engine is being passed the wrong snout position. The snout position is used to determine the penumbra of the beam which includes the calculation of the source si

• • Terminated Z-2200-2015 FDA Class II ·initiated 31 Jul 2014

  Philips, Pinnacle Radiation Treatment Planning System version 8.0h, 8.0k, 8.0m, 8.0n, 9 0, 9 2 9 4, 9 6 is being recalled because the dose may be inconsistent with the density of a density-overridden ROl.

• • Terminated Z-1312-2014 FDA Class II ·initiated 11 Feb 2014 ·on shared 510(k) K041577

  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.

• • Terminated Z-0206-2013 FDA Class II ·initiated 5 Oct 2012 ·on shared 510(k) K041577

  Philips Medical Systems Cleveland), Inc. is recalling Pinnacle3 Virtual Client Connection software version 3.1 due to an improper release and subsequent distribution.

• • Terminated Z-0594-2012 FDA Unclassified (pre-2012) ·initiated 18 Nov 2011 ·on shared 510(k) K041577

  Phillips Medical Systems have recently determined that a software (Pinnacle3 Software version 9.0) nonconformance can cause incorrect beam geometry.

• • Terminated Z-1212-2007 FDA Unclassified (pre-2012) ·initiated 21 Aug 2007 ·on shared 510(k) K041577

  Incorrect Absolute Marking Coordinates when used with PQ-Series scanners due to a software malfunction

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K041577 ↗

FDA Product Code

LNH

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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  Class II

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