Laksell GammaPlan recall
Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment.
Why was Laksell GammaPlan recalled?
Memory can become corrupted when creating a fused study via drag and drop in Leksell GammaPlan 10.2.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software 10.2
- Product
- Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment.
- Recalling firm
- Elekta, Inc.
- Quantity
- 10
- Distribution
- Worldwide Distribution: US (nationwide) including states: IL, OH, PA, TX, and WI; and countries of: Germany, Japan and United Kingdom.
- Recall date
- June 17, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)