[pending] Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software
Pending LLM rewrite. Source: FDA_DEVICE Z-0433-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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
The recalled product
- Product
- Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product Description: The Intended Purpose of Leksell¿ Vantage" Stereotactic System is target localization and fixation of the patient head in a coordinate system in
- Manufacturer
- Elekta, Inc.
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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