# Major Recall Alert: Pinnacle³ 16.2.1 Recalled Due to Software Issue in Radiation Therapy Planning System
The Pinnacle³ 16.2.1 Radiation Therapy Planning System has been recalled following the discovery of a potentially dangerous software issue. This issue impacts the accuracy of the tool during advanced region of interest (ROI) expansion and contraction for non-head first supine (HFS) positioning. When using other orientations—head first prone (HFP), feet first supine (FFS), or feet first prone (FFP)—the software produces a direction error, significantly affecting treatment accuracy and safety. This recall was officially initiated on **June 11, 2025**.
Healthcare professionals and patients relying on this system should take immediate precautions to ensure safe treatment outcomes. Here’s everything you need to know about this critical recall.
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## Why This Recall is Important
The Pinnacle³ Radiation Therapy Planning System is widely used in radiation therapy to help create detailed and accurate treatment plans for cancer patients. The issue arises when using advanced ROI expansion/contraction outside of the HFS orientation. In non-HFS positions, the software misinterprets the direction of expansion and contraction, potentially leading to:
- **Overdose to surrounding healthy structures**
- **Underdose to the intended treatment area**
These inaccuracies can cause serious health risks, compromising treatment effectiveness and patient safety. While the tool functions correctly in HFS positioning, this error makes it unsafe for use in alternative setups.
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## Details of the Recall
Affected Product: Pinnacle³ 16.2.1 Radiation Therapy Planning System
Recall Start Date: June 11, 2025
Key Issue: The software assumes patients are always in the head first supine (HFS) position. When used in HFP, FFS, or FFP positions, it miscalculates ROI expansions.
Potential Risks:
- Overdose to healthy tissues near the treatment area
- Underdose in the intended radiation target
Steps Leading to Error:
1. Therapist or physician conducts patient simulation with HFP, FFS, or FFP image sets.
2. The physician applies advanced ROI expansion/contraction.
3. The software misdirects the ROI expansion/contraction, leading to incorrect treatment parameters.
Ensure to read the official recall notice for full technical details: [Government of Canada Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/pinnacle3-radiation-therapy-planning-system).
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## What You Should Do
If your healthcare facility uses the Pinnacle³ 16.2.1 system, follow these recommended steps immediately:
- **Suspend Use for Non-HFS Treatment Plans**: Until a software update is announced, restrict use to head first supine (HFS) orientation only.
- **Contact Manufacturer Support**: Reach out to the vendor for guidance or potential software patches to remedy the issue.
- **Notify Relevant Team Members**: Ensure your medical staff is fully informed about the risk of miscalculations in non-HFS positions.
- **Patient Safety Measures**: Reassess any treatment plans created with HFP, FFS, or FFP image sets to confirm accuracy and make corrections as needed.
By acting swiftly, healthcare providers can mitigate risks and safeguard patient outcomes.
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## Stay Safe – Get Instant Recall Alerts
Recalls like these highlight the importance of staying informed. Protect your patients and practice by subscribing to real-time updates. Download the **[MyRecalls App](#)** to get immediate alerts about medical, consumer, and product recalls that affect your safety.
Stay proactive and informed—prioritize safety for your team and patients. For more details, visit the official recall page: [Government of Canada Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/pinnacle3-radiation-therapy-planning-system).
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