Severity
Critical
ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.
Reported: November 3, 2021 Initiated: September 22, 2021 #Z-0118-2022 119 (US); 55 (OUS) units
MEDTECH SAS issued this FDA Devices recall on November 3, 2021. Classified as Critical severity (Class I). Approximately 119 (US); 55 (OUS) units are affected. The recall was issued because: The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate pl…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-0118-2022) was formally reported on November 3, 2021, with the manufacturer initiating the action on September 22, 2021. It is classified under Critical severity (Class I), with a current status of Ongoing. MEDTECH SAS is listed as the recalling firm, operating out of Montpellier, N/A. Federal records indicate 119 (US); 55 (OUS) units are affected.
The documented reason for this recall is: 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 iss… Distribution data in the federal record shows the product reached: US Nationwide distribution and International Distribution to countries of: Australia, Taiwan, China, Thailand, Japan, India, South Korea, and the Netherlands.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 5 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
119 (US); 55 (OUS)
Related Recalls
6
6 from same agency
Product Description
ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.
Reason for Recall
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.
Details
- Recalling Firm
- MEDTECH SAS
- Units Affected
- 119 (US); 55 (OUS)
- Distribution
- US Nationwide distribution and International Distribution to countries of: Australia, Taiwan, China, Thailand, Japan, India, South Korea, and the Netherlands.
- Location
- Montpellier, N/A
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-0118-2022 |
| Date reported | November 3, 2021 |
| Date initiated | September 22, 2021 |
| Recalling firm | MEDTECH SAS |
| Units affected | 119 (US); 55 (OUS) |
| Distribution | US Nationwide distribution and International Distribution to countries of: Australia, Taiwan, China, Thailand, Japan, India, South Korea, and the Netherlands. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.. Recalled by MEDTECH SAS. Units affected: 119 (US); 55 (OUS).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 3, 2021. Severity: Critical. Recall number: Z-0118-2022.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution and International Distribution to countries of: Australia, Taiwan, China, Thailand, Japan, India, South Korea, and the Netherlands..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0118-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).