Facility

MEDTECH SAS

4 recall(s) on record — most severe on record: Class I.

Key facts

4recalls · worst Class I

2inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3009185973
Establishment type	Export Device to the United States But Perform No Other Operation on Device
Location	432 rue du Rajol MAUGUIO Occitanie, FR 34130
Registration status	Active · expires 2026
Parent company	MEDTECH S.A.S (owner-operator 10034131)
Brand names	Rosa

Activity by year

Recalls (4)
Inspections (2)

Devices registered here (1)

Drape, Surgical, Antimicrobial
Product code KKX (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4370

Recalls & enforcement

Class IOngoing2021-09-22
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…
Class IITerminated2020-01-06
Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain software, potentially compromising the surgery planning.
Class ITerminated2019-09-10
The instrument holder may be sent on a trajectory that is not within the intended target. If it is not corrected, the associated device may be placed incorrectly.
Class IITerminated2018-05-08
Replacement of units lacking an updated device approval.

FDA inspections (2)

VAI2025-07-24
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2017-11-16
No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by MEDTECH S.A.S

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “MEDTECH SAS (FEI 3009185973) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009185973-medtech-sas/

Not open yet

Alerts for MEDTECH SAS

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.