MEDTECH SAS Recall: ROSA Brain 3.0 Application-Brain
MEDTECH SAS Recall: ROSA Brain 3.0 Application-Brain is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: MEDTECH SAS; Product: ROSA Brain 3.0 Application-Brain; Reason for recall: Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displaye
| Recalling firm | MEDTECH SAS |
|---|---|
| Product | ROSA Brain 3.0 Application-Brain |
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | US Nationwide |
| Recall initiated | 20200106 |
| Recall number | Z-1150-2020 |
| Category | device |
| Country | France |
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