ROSA One 3 — Class II medical device recall Z-1151-2020
Terminated recall by MEDTECH SAS, reported 2020-02-19, distributed nationwide. Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displaye
| Recall number | Z-1151-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDTECH SAS, Montpellier, France |
| Recall initiated | 2020-01-06 |
| Classified | 2020-02-11 |
| Reported by FDA | 2020-02-19 |
| Terminated | 2020-11-05 |
| Distributed | Nationwide (US) |
| Quantity | 39 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 03760244030948, 03760244032492 |
Product
ROSA One 3.1 Brain Application
Reason for recall
Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain software, potentially compromising the surgery planning.
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-1151-2020. 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.