FDA Device recall Z-1151-2020
ROSA One 3.1 Brain Application
- FDA Device
- Class II
- terminated
- Published 2020-02-19
On 2020-02-19 the FDA classified a Class II recall of ROSA One 3.1 Brain Application 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-1151-2020 |
| 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 One 3.1 Brain Application
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 Number / UDI Number: 1) BS19037 / UDI - (01)03760244030948(11)190423(21)BS19037; 2) BS19038 / UDI - (01)037…Serial Number / UDI Number: 1) BS19037 / UDI - (01)03760244030948(11)190423(21)BS19037; 2) BS19038 / UDI - (01)03760244030948(11)190415(21)BS19038; 3) BS19039 / UDI - (01)03760244030948(11)190430(21)BS19039; 4) BS19040 / UDI - (01)03760244030948(11)190513(21)BS19040; 5) BS19041 / UDI - (01)03760244030948(11)190523(21)BS19041; 6) BS19043 / UDI - (01)03760244030948(11)190513(21)BS19043; 7) BS19049 / UDI - (01)03760244032492(11)190730(21)BS19049; 8) BS19050 / UDI - (01)03760244032492(11)190726(21)BS19050; 9) BS19052 / UDI - (01)03760244032492(11)190731(21)BS19052; 10) BS19054 / UDI - (01)03760244032492(11)190912(21)BS19054; 11) BS19057 / UDI - (01)03760244032492(11)191003(21)BS19057; 12) BS19058 / UDI - (01)03760244032492(11)191011(21)BS19058. |
|---|
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-1151-2020%22
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