Use cautionMedical device recall · FDA · Published September 22, 2021
MEDTECH ROSA One 3.1 Brain App: Software error risks surgery errors
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.
The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate placement of an electrode during surgery. The firm has received 3 global complaints related to the issue. An incorrect trajectory could result in serious injury or death if undetected during surgery.
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Contact the company
📍Recalling firmMEDTECH SAS900 Rue Du Mas De Verchant · Montpellier, France
✎ GovInfoNow plain-language explainer
MEDTECH SAS is recalling the ROSA One 3.1 Brain application software for brain surgery tools because a software error could cause incorrect electrode placement during surgery, potentially leading to serious injury or death. This recall follows three global complaints about the issue. Read more at govinfonow.com/recall/61769-medtech-rosa-one-3-1-brain-app-software-error-risks.
“MEDTECH ROSA One 3.1 Brain App: Software error risks surgery errors.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61769-medtech-rosa-one-3-1-brain-app-software-error-risks. Based on FDA recall #Z-0118-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0118-2022%22&limit=1).
The FDA announced on Sept. 22, 2021, that MEDTECH SAS is recalling the ROSA One 3.1 Brain application due to a software anomaly causing inaccurate electrode placement during surgery. This defect could result in serious injury or death if undetected.
How to tell if you have it
Brand: MEDTECH SAS
Product: ROSA One 3.1 Brain application
US Serial Numbers: BS16904 through BS21138 (specific list provided in record)
OUS Serial Numbers: BS15902 through BS21134 (specific list provided in record)
Units: 119 in US; 55 internationally
The hazard
The firm identified a software anomaly in the ROSA One 3.1 Brain application that led to inaccurate placement of an electrode during surgery. The FDA said an incorrect trajectory could result in serious injury or death if undetected. The firm has received three global complaints related to this issue.
Context
GovInfoNow's records show MEDTECH SAS has issued three other recalls since May 8, 2018, including a Jan. 6, 2020 recall for ROSA Brain 3.0 Application due to image reconstruction errors and a Sept. 10, 2019 recall for the Rosa Brain 3.0 Device regarding incorrect placement risks. Other recent recalls of similar products include the Mazor X Robotic System Software Errors Risk Incorrect Spinal Surgery (Dec. 10, 2025), Medtronic Vanta CP App Software Recall: Risk of Prolonged Surgery (Dec. 3, 2025), and Da Vinci Surgical System: Software Error May Cause Instrument Failure (Nov. 7, 2025).
How to tell if you have this one
Check if your ROSA One 3.1 Brain application software has a serial number listed in the provided range (US and OUS serial numbers are detailed in the recall notice).
Brand
MEDTECH SAS
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your ROSA One 3.1 Brain application software version matches the affected serial numbers listed in the recall.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution and International Distribution to countries of: Australia, Taiwan, China, Thailand, Japan, India, South Korea, and the Netherlands.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0118-2022 (September 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0118-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.