FDAFDA · Food and drugs·Recall number Z-1412-2019
Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
Published May 29, 2019 · Recall initiated: June 27, 2018
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Elekta Instrument AB
- Distributor
- 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.
- Lot
- Software Version 11.1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Sweden
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