Class II — Elekta, Inc.
| Recalling firm | ELEKTA AB |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There have been reports of excessive heating in the MRL Gradient Connection Module. |
| Product | Elekta Unity, Image-Guided Radiation Therapy System |
| Quantity | 21 devices |
| Distribution | Distributed in US - PA, NY, and IA. Distributed ROW - Australia, Canada, China, Switzerland, Denmark, Hong Kong, Italy, Netherlands, Sweden, Thailand, Turkey, UK. There was no government/military distribution. |
| Initiated | 2019-12-18 |
| Classified | 2020-06-30 |
| Terminated | 2021-06-15 |
| Recall number | Z-2473-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Elekta, Inc. (Z-2473-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85620/
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