FDA Device recall Z-2289-2020
Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radiation therapy treatments and…
- FDA Device
- Class II
- terminated
- Published 2020-06-17
On 2020-06-17 the FDA classified a Class II recall of Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radiation therapy treatments and… by Elekta, citing potential risk that Legionella may be present in the Unity machine room, specifically the heat exchanger condensation collection tray.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2289-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-30 |
| Published | 2020-06-17 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Elekta |
| Distribution | US |
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
potential risk that Legionella may be present in the Unity machine room, specifically the heat exchanger condensation collection tray.
Identifiers
| code_info | Serial numbers 600001 - 600043 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2289-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.