Class II — MEDTECH SAS
| Recalling firm | MEDTECH S.A.S |
|---|---|
| Registered facility | MEDTECH SAS (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | ROSA Brain 3.0 Application-Brain |
| Quantity | 47 units |
| Distribution | US Nationwide |
| Initiated | 2020-01-06 |
| Classified | 2020-02-11 |
| Terminated | 2020-11-05 |
| Recall number | Z-1150-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — MEDTECH SAS (Z-1150-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84642/
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