Facility

QUANTUM SURGICAL SAS

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

—inspections in our data

—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)	3023140882
Establishment type	Manufacture Medical Device
Location	1000 rue du mas de verchant montpellier Herault, FR 34000
Registration status	Active · expires 2026
Parent company	Quantum Surgical SAS (owner-operator 10085404)

Activity by year

Recalls (2)

Devices registered here (1)

General Surgery Tray
Product code LRO (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4370

Recalls & enforcement

Class IIOngoing2025-05-23
Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
Class IICompleted2024-08-05
Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.

All facilities operated by Quantum Surgical SAS

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. “QUANTUM SURGICAL SAS (FEI 3023140882) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3023140882-quantum-surgical-sas/

Not open yet

Alerts for QUANTUM SURGICAL 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.