Reported May 6, 2026 · Ongoing
Brand Name: Leksell Vantage Arc System REF: 1053958
Elekta, Inc.
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, Inc. · 400 Perimeter Center Ter NE Ste 50 · Atlanta, GA · 30346-1227
Is this the product you have?
- Brand NameLeksell
- Vantage Arc System REF1053958
- Lot codes and dates
- Lot CodeArc
- SystemUDI:07340048304856
- Parts of Arc SystemLeft
- Z-SlideSerial
- NumbersUDI: 07340048304818 00001 00625
- Right Z-SlideUDI: 07340048304801/
- Serial Numbers00001 00675
- Amount recalled
- 768 (364Left/364Right)
Where it was sold
Why it was recalled
Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
This product could cause temporary or reversible health problems — stop using it.
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