FDA Device recall Z-1150-2020
ROSA Brain 3.0 Application-Brain
- FDA Device
- Class II
- terminated
- Published 2020-02-19
On 2020-02-19 the FDA classified a Class II recall of ROSA Brain 3.0 Application-Brain by Medtech Sas, citing 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 sof….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1150-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-06 |
| Published | 2020-02-19 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medtech Sas |
| Distribution | US |
Product
ROSA Brain 3.0 Application-Brain
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.
Identifiers
| code_info | Serial Numbers: BR16004, BR16005, BR16006, BR16009, BR16010, BR16011, BR16012, BR16014, BR16015, BR16016, BR…Serial Numbers: BR16004, BR16005, BR16006, BR16009, BR16010, BR16011, BR16012, BR16014, BR16015, BR16016, BR16017, BR16018, BR16021, BR16023, BR16025, BS16904, BS16905, BS16910, BS16916, BS16917, BS16923, Additional Serial Numbers / UDI: 1) BR17030 / UDI - (01)03760244031754(11)180309(21)BR17030; 2) BR17034, BS17934 / UDI - (01)03760244031754(11)180315(21)BR17034; 3) BR17035, BS17935 / UDI - (01)03760244031754(11)180315(21)BR17035; 4) BR17036 / UDI - (01)03760244031754(11)180417(21)BR17036; 5) BR17037, BS17937 / UDI - (01)03760244031754(11)180313(21)BR17037; 6) BR18024 / UDI - (01)03760244031754(11)180321(21)BR18024; 7) BR18031 / UDI - (01)03760244031754(11)180309(21)BR18031; 8) BR18038 / UDI - BS18938 "(01)03760244031754(11)180430(21)BR18038; 9) BR18039 / UDI - (01)03760244031754(11)180416(21)BR18039; 10) BR18040, BS18940 / UDI - (01)03760244031754(11)180427(21)BR18040; 11) BR18041, BS18941 / UDI - (01)03760244031754(11)180329(21)BR18041; 12) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1150-2020%22
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