[pending] Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma
Pending LLM rewrite. Source: FDA_DEVICE Z-1581-2026.
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 adapter not being properly aligned or locked in place.
The recalled product
- Product
- Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta Esprit Leksell Gamma Knife¿ (available models Elekta Esprit, Icon", and Perfexion") is a radiosurgery system for use in the stereot
- Manufacturer
- Elekta, Inc.
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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