The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manu
Summary
The FDA issued a Class II for The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device int by QUANTUM SURGICAL SAS. Reason: Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust..
Details
Source
Device Recall
External ID
Z-0037-2025
Action Date
2024-10-16
Status
Completed
Category
device
Product Description
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.
Lot/Code Info: UDI/DI 37603054002NGXL, serial numbers: 0321015 and 0321017
Quantity Affected: 2 units
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.
Distribution
US Nationwide distribution in the state of FL.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-05
Company
montpellier
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 123 device recalls issued in the same week, part of 403 device-related FDA actions this month.
QUANTUM SURGICAL SAS has 3 FDA actions in our database, including 2 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (QUANTUM SURGICAL SAS) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does QUANTUM SURGICAL SAS have FDA actions?
QUANTUM SURGICAL SAS has 3 FDA actions in our database, including 2 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0037-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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