Reported Nov 12, 2025 · Ongoing
Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product…
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
- Stereotactic System Product NameLeksell Vantage
- Stereotactic System Software Versionn/a
- Product DescriptionThe Intended Purpose of Leksell¿ Vantage" Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments
- Lot codes and dates
- Lot CodeUDI
- ReferencesArc: 07340048304856
- Support Arc07340048304849 Arcs
- and Support Arcs with Serial NumbersSH00001-SH00338
- Amount recalled
- 338
Where it was sold
Why it was recalled
Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound
This product could cause temporary or reversible health problems — stop using it.
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