MEDTECH SAS recalls
Every recall we track for MEDTECH SAS — 5 in all, from 2018–2021 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
5 recalls since 2017.
All FDA recall records for MEDTECH SAS since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 1 | 1 |
| 2019 | 0 | 1 | 0 | 0 | 1 |
| 2020 | 0 | 0 | 2 | 0 | 2 |
| 2021 | 0 | 1 | 0 | 0 | 1 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled MEDTECH SAS product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All MEDTECH SAS recalls
4 shown- Use cautionMedical device
MEDTECH SAS recalls ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments
MEDTECH SAS recalls ROSA One 3.1 Brain application software due to potential inaccurate electrode placement during brain surgery, risking serious injury or death. Affected units have specific serial numbers.
MEDTECH SASSep 22, 2021 - Lower riskMedical device
MEDTECH SAS recalls ROSA Brain 3.0 Application-Brain
MEDTECH SAS recalls ROSA Brain 3.0 Application-Brain software with specific serial numbers due to potential image reconstruction errors that could compromise surgery planning. Affected units include 70 serial numbers listed in the recall notice.
MEDTECH SASJan 6, 2020 - Use cautionMedical device
MEDTECH SAS recalls Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic
MEDTECH SAS recalls Rosa Brain 3.0 (Model ROSA 3.0) due to potential incorrect placement of surgical instruments during neurosurgery. The device is delivered assembled in a wooden case with plastic protection.
MEDTECH SASSep 10, 2019 - UnratedMedical device
MEDTECH SAS recalls ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical
MEDTECH SAS recalls ROSA Robotized Stereotactic Assistant Version 2.5 due to outdated device approval. Affected units have specific serial numbers listed. No remedy is provided in the recall notice.
MEDTECH SASMay 8, 2018
MEDTECH SAS recall questions
How many recalls has MEDTECH SAS had?
5 recalls from MEDTECH SAS are on record with U.S. safety agencies, from 2018–2021.
What is the most recent MEDTECH SAS recall?
MEDTECH SAS recalls ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments, dated Sep 22, 2021. Every MEDTECH SAS recall is listed on this page, newest first.
What should I do if I have a recalled MEDTECH SAS product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new MEDTECH SAS recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.