[pending] Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta
Pending LLM rewrite. Source: FDA_DEVICE Z-1164-2026.
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 a manufacturing issue and electrical grounding of systems.
The recalled product
- Product
- Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version: N/A Product Description: Digital Linear Accelerator Component: No
- Manufacturer
- Elekta, Inc.
- Category
- Medical Device — Devices
Distribution
Distribution scope not specified by the agency.
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