Reported May 29, 2019 · Ongoing
Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife…
Elekta Instrument AB
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Elekta Instrument AB · Kungstensgatan 18 · Stockholm, N/A · N/A
Is this the product you have?
- Leksell GammaPlan 11.1
- Product UsageLeksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning
- Lot codes and dates
- Software Version 11.1
- Amount recalled
- 52 devices
Where it was sold
Why it was recalled
The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.
This product could cause temporary or reversible health problems — stop using it.
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