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Unrated Medical device recall · FDA · Published May 8, 2018

MEDTECH SAS Recalls ROSA Surgical Device: Outdated Software Approval Risk

MEDTECH SAS recalls ROSA Robotized Stereotactic Assistant Version 2.5 due to outdated device approval.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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2108-2018Medical deviceMEDTECH SAS ›
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Contact the company

Recalling firmMEDTECH SASParc Euromedecine Batiment 8, 1006 rue de la Croix Verte · Montpellier, France
✎ GovInfoNow plain-language explainer

MEDTECH SAS is recalling certain versions of their ROSA Surgical Device because they lack an updated device approval. This could pose a risk if the device is used without the latest regulatory clearance. Read more at govinfonow.com/recall/71169-medtech-sas-recalls-rosa-surgical-device-outdated-software-approval-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/71169-medtech-sas-recalls-rosa-surgical-device-outdated-software-approval-risk · Updated August 21, 2026 · FDA enforcement record: FDA #Z-2108-2018

Cite this page

“MEDTECH SAS Recalls ROSA Surgical Device: Outdated Software Approval Risk.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71169-medtech-sas-recalls-rosa-surgical-device-outdated-software-approval-risk. Based on FDA recall #Z-2108-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2108-2018%22&limit=1).

MEDTECH SAS recalled 29 ROSA(TM) Robotized Stereotactic Assistant units because they lack updated device approval, the FDA said on May 8, 2018. Owners should contact MEDTECH SAS for replacement.

How to tell if you have it

  • Brand: MEDTECH SAS
  • Product: ROSA(TM) Robotized Stereotactic Assistant, Version 2.5
  • Serial Numbers: RO 10 009, RO 10 011, RO 10 014, RO 13 023, RO 13 027, RO 14 031, RO 14 033, RO 14 035, RO 14 038, RO 14 039, RO 14 040, RO 14 041, RO 14 043, RO 15 044, RO 15 045, RO 15 046, RO 15 050, RO 15 051, RO 15 052, RO 15 053, RO 15 054, RO 15 058, RO 15 059, RO 15 060, RO 15 061, RO 15 063, RO 15 064, RO 15 067, RO 15 069
  • Quantity: 29 units

The hazard

The recall addresses units lacking an updated device approval. The ROSA Surgical Device is a computer-controlled electromechanical arm intended for use by neurosurgeons to guide standard neurosurgical instruments.

Context

GovInfoNow's records show MEDTECH SAS has 3 other recalls on record since 2019-09-10. Other recent recalls of similar products include ROSA One 3.1 Brain App (2021-09-22), ROSA One 3.1 Brain Application (2020-01-06), and Rosa Brain 3.0 Device Recall (2019-09-10).

How to tell if you have this one

Check if your ROSA Surgical Device has a serial number starting with RO followed by numbers (e.g., RO 10 009). The recall includes specific serial numbers listed in the notice.

  • Brand
    MEDTECH SAS
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Serial Number

    Identify the serial number on your ROSA Surgical Device to see if it matches the list of affected units provided in the recall notice.

How this recall unfolded

Recall timeline

FDA terminated this recall 2.3 years after the firm started it.

1. Firm started the recall: May 8, 201812. FDA classified it Class II: Jun 7, 201823. Published in FDA’s Enforcement Report: Jun 13, 201834. FDA terminated the recall: Aug 19, 2020420182020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Why is this device being recalled?

The recall is due to replacement of units lacking an updated device approval. This ensures the device meets current safety and regulatory standards.

Are there any safety risks if the device is used without the update?

The recall indicates a risk of outdated device approval, but the specific hazard mechanism is not detailed in the notice.

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Where this comes from

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-2108-2018 (May 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2108-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 21, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA