Elekta Recalls Leksell GammaPlan Software Due to Memory Corruption
Elekta is recalling 10 units of Leksell GammaPlan 10.2 software because memory can become corrupted when creating a fused study via drag and drop.
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 is classified as FDA Class II and involves a medical device software defect that could impact treatment planning, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Elekta, Inc. is recalling 10 units of Leksell GammaPlan 10.2, a computer-based dose planning system designed for use with the Leksell Gamma Knife radiation therapy treatment. The recall was initiated because memory can become corrupted when creating a fused study via drag and drop in the software.
The affected software was distributed worldwide, including nationwide in the United States (specifically in Illinois, Ohio, Pennsylvania, Texas, and Wisconsin) and in Germany, Japan, and the United Kingdom. The recall is classified as Class II by the FDA.
Consumers and healthcare facilities should contact Elekta, Inc. for further instructions regarding the recall and potential software updates or replacements.
The recalled product
- Product
- Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment.
- Manufacturer
- Elekta, Inc.
- Affected units
- 10
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 10.2
Distribution
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