Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan recall
Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
Why was Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan recalled?
The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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 Version 11.1
- Product
- Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
- Recalling firm
- Elekta Instrument AB
- Quantity
- 52 devices
- Distribution
- Worldwide Distribution - US Nationwide distribution to GA, MD, NJ, PA, PR, WA. International distribution to Australia, Belgium, France, Germany, Hong Kong, Italy, Japan, Korea, Democratic People's Republic of, Netherlands, Romania, Russian Federation, Spain, Turkey, United Kingdom.
- Recall date
- May 29, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)