Z-0037-2025Class II

The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the...

Name: Z-0037-2025 The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the...
Creator: Quantum Surgical Sas
Published: 2024-08-05
License: https://open.fda.gov/license/

Quantum Surgical SAS / initiated 2024-08-05 / Completed

FDA source

QUANTUM SURGICAL SAS began a recall of The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of one or more... on 2024-08-05. FDA classified it as Class II and gives the reason as "Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust". As of 2026-09-10, the recall status on record is Completed.

Recall record

Recall number: Z-0037-2025
Classification: Class II
Status: Completed
Initiated: 2024-08-05
Posted: 2024-10-09
Recalling firm: Quantum Surgical SAS
Product: The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device 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 procedures. During the planning phase, the desired instrument placement and performance is defined relative to the target anatomy. During the guidance phase, the device enables to monitor respiratory levels and verify patient position prior to instrument advancement. During the assessment phase, the achieved instrument placement and performance are displayed relative to the previously defined plan through an overlay of the pre- and post-treatment image data.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.
FDA root cause: Under Investigation by firm
Action: Quantum Surgical issued an URGENT FIELD SAFETY NOTICE to its sole consignee via visit on 08/05/2024 and followed up with an email on 08/19/2024. The notice explained the problem, potential risk, and requested that the consignee cease use of the device. The affected units were returned, repaired, and replaced.
Quantity in commerce: 2 units
Distribution: US Nationwide distribution in the state of FL.
Product codes and lots: UDI/DI 37603054002NGXL, serial numbers: 0321015 and 0321017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0037-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0037-2025	Class II	Completed	Voluntary: Firm initiated	2024-10-16	2024-10-09

Product code JAK

K223758Class IIEpioneQuantum Surgical Sas / cleared 2023-05-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)