Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 13, 2018
ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It
Replacement of units lacking an updated device approval.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtech Sas recalled ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a com… - a moderate-severity action.
ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a com… was recalled by Medtech Sas in June 13, 2018. Reason: Replacement of units lacking an updated device approval.. Check the official notice for the remedy. Verify recall #Z-2108-2018 with the FDA Devices before acting.
The recall
Medtech Sas issued this moderate-severity FDA Devices recall-Replacement of units lacking an updated device approval..
- Moderate
- severity level
- 29 units
- affected scope
- Class II
- classification
- June 13, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2108-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2108-2018) was formally reported on June 13, 2018, with the manufacturer initiating the action on May 8, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Medtech Sas is listed as the recalling firm, operating out of Montpellier, N/A. Federal records list the affected scope as 29 units.
The documented reason for this recall is: Replacement of units lacking an updated device approval. Distribution data in the federal record shows the product reached: US Distribution. 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
29 units
Related Recalls
6
3 from same agency
Product description
ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.
Reason for recall
Replacement of units lacking an updated device approval.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2108-2018 |
| Date reported | June 13, 2018 |
| Date initiated | May 8, 2018 |
| Recalling firm | Medtech Sas |
| Firm location | Montpellier, N/A |
| Affected scope | 29 units |
| Distribution | US Distribution |
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-2108-2018) 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.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.. Recalled by Medtech Sas. Units affected: 29 units.
Why was this product recalled? ▼
Replacement of units lacking an updated device approval.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 13, 2018. Severity: Moderate. Recall number: Z-2108-2018.
Where was the recalled product distributed? ▼
Distribution: US Distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2108-2018) 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 June 13, 2018. 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.