Elekta Unity — Class II medical device recall Z-2289-2020
Terminated recall by Elekta, Inc., reported 2020-06-17, distributed nationwide. potential risk that Legionella may be present in the Unity machine room, specifically the heat exchanger conde
| Recall number | Z-2289-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2020-04-30 |
| Classified | 2020-06-05 |
| Reported by FDA | 2020-06-17 |
| Terminated | 2021-08-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, CN, DE, DK, GB, HK, IT, NL, SE, TH, TR |
| Quantity | 32 units |
| UPC / GTIN / UDI-DI | 05060191071321 |
| Serial numbers | 600001, 600043 |
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.
Reason for recall
potential risk that Legionella may be present in the Unity machine room, specifically the heat exchanger condensation collection tray.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2289-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.