EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device… — Class II medical device recall Z-1927-2025

Ongoing recall by QUANTUM SURGICAL SAS, reported 2025-06-18, distributed nationwide. Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by

Recall number	`Z-1927-2025`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	QUANTUM SURGICAL SAS, montpellier, France
Recall initiated	2025-05-23
Classified	2025-06-09
Reported by FDA	2025-06-18
Distributed	Nationwide (US)
Countries outside the US	DE, FR, GB
Quantity	4 units
Reason classes	software
UPC / GTIN / UDI-DI	`03760305400031`
Serial numbers	`0322002`, `0323003`, `0323006`, `0324001`
Model numbers	`30-0001`

Product

EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous ablation procedures in the abdomen, performed by physicians trained for CT procedures and performed under general anaesthesia with rigid straight instruments such as needles and probes of diameters ranging from 11G to 19G.

Reason for recall

Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1927-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.