# Major Recall Alert: Leksell GammaPlan® Recalled Due to Potential Patient Risk Linked to Reference Misalignment
Safety remains a top priority in healthcare technologies, especially when precision is critical for treatment success. **Leksell GammaPlan®**, a software product designed for stereotactic radiosurgery planning, has been recalled due to a critical flaw that could result in severe patient safety risks. This recall highlights the imperative need for accurate software alignment to avoid potential irradiation of the wrong patient location.
The issue, announced on **31034**, is receiving attention from healthcare providers across Canada.
## Why This Recall is Important
The recall revolves around a specific software issue in the **Leksell GammaPlan®** system. If a new stereotactic reference for a frame treatment is defined without first changing an obsolete reference to a pre-plan reference, the system may create an **inconsistent alignment**. This error, if left undetected, could lead to the irradiation of the **wrong patient location**, posing significant safety concerns for patients undergoing critical radiological treatments.
Radiation treatments rely heavily on precise targeting to address conditions such as tumors while preserving healthy surrounding tissue. An error in alignment directly undermines this treatment goal, putting patients at unnecessary risk of harm.
## Details of the Recall
The Canadian government’s official recall notice outlines the following key details:
- **Impacted Product**: Leksell GammaPlan®
- **Reason for Recall**: Defining a new stereotactic reference without replacing an outdated reference system may cause overlay and alignment inconsistencies, which, if undetected, could lead to incorrect treatment.
- **Safety Concern**: Misalignment issues could result in the irradiation of areas outside the target zone, increasing the risk to the patient’s health.
- **Date of Announcement**: 31034
This recall is a stark reminder of the importance of maintaining up-to-date and accurate references in medical software.
For the official recall notice, visit the [Government of Canada’s recall page](https://recalls-rappels.canada.ca/en/alert-recall/leksell-gammaplanr).
## What You Should Do
Healthcare facilities and users of the Leksell GammaPlan® system are urged to take the following steps to ensure patient and equipment safety:
1. **Cease Use of the System Immediately**: Pause all use of the Leksell GammaPlan® product until corrective measures and updates are implemented as per the manufacturer's instructions.
2. **Contact the Manufacturer**: Reach out to the product’s manufacturer to understand the necessary steps, software updates, or technical fixes that will address the issue.
3. **Review Current Patient Data**: Double-check all planned treatment references for accuracy to ensure no errors lead to treatment at an unintended patient site.
4. **Train Staff**: Ensure all personnel are informed about this issue and trained to apply updated safety protocols once the issue is resolved.
5. **Monitor for Updates**: Stay connected with recall announcements and follow-up instructions from the manufacturer or authorized Canadian health authorities.
## Stay Safe – Get Instant Recall Alerts
Staying on top of safety recalls is critical for protecting patients and ensuring compliance in your medical facility. Don’t miss vital updates like this one!
📱 **Download the Recall App** today to get instant notifications about product recalls that can affect you or your practice. Be the first to know about critical safety updates, ensuring the well-being of your patients and the reliability of your healthcare services.
Keep your patients safe and your team informed by acting swiftly on recalled products like this one. Visit the official **Leksell GammaPlan® recall page** [here](https://recalls-rappels.canada.ca/en/alert-recall/leksell-gammaplanr) to learn more.
**Your attention to detail could save lives.**