Elekta Unity — Class II medical device recall Z-2297-2020
Terminated recall by Elekta Limited, reported 2020-06-17, distributed in IA, NY, PA, TX, WI. In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a mismat
| Recall number | Z-2297-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta Limited, Crawley, N/A, United Kingdom |
| Recall initiated | 2020-05-21 |
| Classified | 2020-06-08 |
| Reported by FDA | 2020-06-17 |
| Terminated | 2024-08-19 |
| Distributed | IA, NY, PA, TX, WI |
| Countries outside the US | AU, CA, CH, CN, DE, DK, GB, HK, IT, NL, SE, TR |
| Quantity | 26 units |
| UPC / GTIN / UDI-DI | 05060191071321 |
Product
Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571
Reason for recall
In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a mismatch between the contour data overlay with respect to the motion monitoring images of the monitored structure.
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-2297-2020. 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.