Elekta Unity — Class II medical device recall Z-1980-2019
Terminated recall by Elekta, Inc., reported 2019-07-24, distributed in TX, WI. The QA software solution to perform the MR to MV alignment check, does not display the stored MR to MV offset
| Recall number | Z-1980-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2019-06-24 |
| Classified | 2019-07-16 |
| Reported by FDA | 2019-07-24 |
| Terminated | 2021-04-01 |
| Distributed | TX, WI |
| Countries outside the US | CA, DE, DK, GB, IT, NL, SE |
| Quantity | 12 units |
| Reason classes | software |
Product
Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging 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
The QA software solution to perform the MR to MV alignment check, does not display the stored MR to MV offset values. The user is unable to independently inspect the values during their QA.
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-1980-2019. 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.