EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory int
Summary
The FDA issued a Class II for EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a use by QUANTUM SURGICAL SAS. Reason: Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user..
Details
Source
Device Recall
External ID
Z-1927-2025
Action Date
2025-06-18
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: Model Number: 30-0001 UDI-DI code: 03760305400031 Software Version: 1.0.6.1 Serial Numbers (U.S.): 0322002, 0323006, 0323003 and 0324001
Quantity Affected: 4 units in U.S.
Reason for Recall
Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
Distribution
Worldwide distribution - U.S. Nationwide distribution in the states of FL,IL, IN, and TX. The countries of France, Germany and United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-23
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 180 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-1927-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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