Official recall notice
FDA DeviceClass IINotable
FDA Recall: Brand Name: Leksell Vantage Arc System REF: 1053958
- Recall date
- 2026-05-06
- Brand
- Elekta, Inc.
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
Recommended action
What to do
768 (364Left/364Right)
Product description
Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.