Facility

Medimaps Group SA

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)	3010208539
Establishment type	Manufacture Medical Device
Location	36A Chemin Du Champ des Filles Plan-les-Ouates Geneve, CH CH-1228
Registration status	Active · expires 2026
Parent company	Medimaps SA (owner-operator 10042744)
Brand names	TBS iNsight

Activity by year

Recalls (2)

Devices registered here (1)

Densitometer, Bone
Product code KGI (opens in a new tab) · Class II · Radiology · 21 CFR 892.1170

Recalls & enforcement

Class IIOngoing2025-02-03
Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines.
Class IITerminated2016-10-03
The FRAX adjusted for TBS values are not correct when: The FRAX feature is activated in TBS iNsight; and TBS has been computed from a spine scan where some vertebrae were excluded.

All facilities operated by Medimaps SA

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. “Medimaps Group SA (FEI 3010208539) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010208539-medimaps-group-sa/

Not open yet

Alerts for Medimaps Group SA

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.