Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported November 3, 2021
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.
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 receive…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtech Sas recalled ROSA One 3.1 Brain application The device is intended for the spatial positioning and … - a critical-severity action.
ROSA One 3.1 Brain application The device is intended for the spatial positioning and … was recalled by Medtech Sas in November 3, 2021. Reason: The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the ina…. Check the official notice for the remedy. Verify recall #Z-0118-2022 with the FDA Devices before acting.
The recall
Medtech Sas issued this critical-severity FDA Devices recall-The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the ina….
- Critical
- severity level
- Class I
- classification
- November 3, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0118-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
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 list the affected scope as 119 (US); 55 (OUS).
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.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
119 (US); 55 (OUS)
Related Recalls
6
3 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.
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 |
| Firm location | Montpellier, N/A |
| Affected scope | 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.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0118-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 3, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.