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Pinnacle³ radiation therapy planning system
Official notice
19 Aug 2025
An official Health Canada notice concerns Pinnacle³ radiation therapy planning system. 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 Published 2025-08-19.
What to do now
Contact the manufacturer if you require additional information.
Recall number
77629
Official notice
2025-08-19
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Affected products
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Philips, Pinnacle³ Radiation Therapy Planning System.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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