Elekta Unity systems Product Usage: Elekta Unity using Magnetic… — Class II medical device recall Z-1297-2019
Terminated recall by Elekta Limited, reported 2019-05-15, distributed nationwide. There is no warning in the Elekta Unity manual for the administration of gadolinium-based or other contrast ag
| Recall number | Z-1297-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta Limited, Crawley, N/A, United Kingdom |
| Recall initiated | 2019-04-03 |
| Classified | 2019-05-08 |
| Reported by FDA | 2019-05-15 |
| Terminated | 2023-05-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, DK, GB, IT, NL |
| Quantity | 9 devices |
Product
Elekta Unity systems Product Usage: 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. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems.
Reason for recall
There is no warning in the Elekta Unity manual for the administration of gadolinium-based or other contrast agents for imaging or image guidance purposes has not been validated.
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-1297-2019. 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.