Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta
Pending LLM rewrite. Source: FDA_DEVICE Z-1164-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
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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