Elekta Unity — Class II medical device recall Z-1109-2019
Terminated recall by Elekta Limited, reported 2019-04-17, distributed nationwide. Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The images acquir
| Recall number | Z-1109-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta Limited, Crawley, N/A, United Kingdom |
| Recall initiated | 2019-03-12 |
| Classified | 2019-04-08 |
| Reported by FDA | 2019-04-17 |
| Terminated | 2023-11-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, DK, GB, IT, NL, SE |
| Quantity | 12 units |
| Reason classes | software |
Product
Elekta Unity, Image-Guided Radiation Therapy System 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
Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The images acquired using these protocols do not represent the average position of the anatomy during the respiratory motion cycle. The images are based on data acquired around full expiration. 2) The display of the images in the Elekta Unity Application software does not provide information about the protocol used to acquire the image eg. with or without respiratory triggering. Users must select an appropriate scan protocol that is representative of the respiratory phase used in the reference plan.
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-1109-2019. 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.