FDAJune 27, 2018device
Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.
What to do
FDA enforcement status: Ongoing
Brands named
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Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAMOSAIQ Oncology Information System2026-05-21
- FDABrand Name: Leksell Vantage Arc System REF: 10539582026-03-19
- FDAeTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-1572026-03-02
- FDAeTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-1512026-03-02
- FDAeTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-1562026-03-02
- FDAeTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-1522026-03-02
- FDAeTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-1502026-03-02
- FDAeTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-1582026-03-02
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