Official recall record

Pinnacle³ Radiation Therapy Planning System

What the authority reported

There is a software issue affecting Pinnacle³ Radiation Therapy Planning System performing advanced region of interest (ROI) expansion and contraction that results in a potential shift of the intended ROI. The software assumes the patient is always in the head first supine (HFS) position when transposing the advanced expansion to alternate positions. While performing advanced region of interest (ROI) expansion and contraction in the HFS position, the tool works as intended. However, when performing advanced ROI expansion and contraction on HFP, FFS, or FFP orientation images sets, a direction error occurs which results in potential overdose to nearby structure or potential underdose in the treatment plan. The following steps will lead to the software issue described above: Therapist / physician performs simulation based on HFP, FFS, and FFP images Physician performs advanced variable ROI expansion/contraction There is an error in direction of expansion/contraction Recall start date: June 11, 2025

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

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