Elekta Unity — Class II medical device recall Z-2473-2020
Terminated recall by Elekta, Inc., reported 2020-07-08, distributed in IA, NY, PA. There have been reports of excessive heating in the MRL Gradient Connection Module.
| Recall number | Z-2473-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2019-12-18 |
| Classified | 2020-06-30 |
| Reported by FDA | 2020-07-08 |
| Terminated | 2021-06-15 |
| Distributed | IA, NY, PA |
| Countries outside the US | AU, CA, CH, CN, DK, GB, HK, IT, NL, SE, TH, TR |
| Quantity | 21 devices |
| Serial numbers | 600014, 600016, 600017, 600018, 600019, 600020, 600021, 600022, 600023, 600024, 600025, 600026, 600027, 600028, 600029, 600030, 600031, 600032, 600033, 600034, 600035 |
Product
Elekta Unity, Image-Guided Radiation Therapy System
Reason for recall
There have been reports of excessive heating in the MRL Gradient Connection Module.
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-2473-2020. 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.