Facility

OLEA MEDICAL

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

Key facts

1recalls · 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)	3007675959
Establishment type	Manufacture Medical Device
Location	93 Avenue du Sorbier, Zone Athelia IV La Ciotat Bouches-du-Rhone, FR 13600
Registration status	Active · expires 2026
Parent company	Olea Medical S.A.S. (owner-operator 10028761)
Brand names	Neurovascular Insight V1

Activity by year

Recalls (1)

Devices registered here (1)

System, Image Processing, Radiological
Product code LLZ (opens in a new tab) · Class II · Radiology · 21 CFR 892.2050

Recalls & enforcement

Class IIOngoing2023-08-10
When exporting regions of interest in DICOM SEGMENTATION format, when simultaneously exporting multiple volumes of interest, a functional magnetic resonance software bug may cause file contents and associated series descriptions to not match, which could lead to a misinterpretati…

All facilities operated by Olea Medical 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. “OLEA MEDICAL (FEI 3007675959) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007675959-olea-medical/

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