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 | potential risk that Legionella may be present in the Unity machine room, specifically the heat exchanger condensation collection tray. |
| Product | Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. |
| Quantity | 32 units |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of PA, WI, NY, TN, NJ, IA, TX, and the countries of Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Thailand, Turkey, UK. |
| Initiated | 2020-04-30 |
| Classified | 2020-06-05 |
| Terminated | 2021-08-04 |
| Recall number | Z-2289-2020 |
| 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-2289-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85651/
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