Linear accelerators recalled over a manufacturing and electrical grounding issue
Elekta is recalling 5,391 medical linear accelerators, covering Elekta Synergy, Harmony, Infinity and Versa HD, due to a manufacturing issue and electrical grounding of systems.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites a manufacturing and grounding issue with no stated consequence or reported harm.
Plain-English summary
The Elekta Medical Linear Accelerator, covering the Elekta Synergy, Elekta Harmony, Elekta Infinity and Versa HD digital linear accelerators, is being recalled by Elekta, Inc.
The reason given in the enforcement record is a manufacturing issue and electrical grounding of systems.
The record lists 5,391 units, with lot codes recorded in the enforcement record. Distribution is given as worldwide. The FDA has classified the action as Class II.
The record names no consequence and reports no injuries. Facilities should follow Elekta's instructions.
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.
- Affected units
- 5,391
Distribution
Distribution scope not specified by the agency.
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