Elekta Recalls Leksell GammaPlan 11.1 Software Due to Margin Overestimation
Elekta Instrument AB is recalling Leksell GammaPlan 11.1 software because the margin tool overestimates treatment margins in certain areas.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software defect that affects treatment planning accuracy. While no specific injuries are reported in the source text, the risk of harm from inaccurate radiation treatment planning places this in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Elekta Instrument AB is recalling Leksell GammaPlan 11.1, a computer-based system designed for Leksell Gamma Knife treatment planning. The recall involves 52 devices distributed worldwide, including in the United States and various international locations.
The recall is issued because the margin tool in the software systematically overestimates margin in certain areas of the volume. This defect could impact the accuracy of treatment planning for Gamma Knife procedures.
Healthcare facilities using this software should contact Elekta Instrument AB for further instructions on how to address the issue.
The recalled product
- Product
- Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
- Manufacturer
- Elekta Instrument AB
- Category
- Medical Device — Software
- Affected units
- 52
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Software Version 11.1
Distribution
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