FDA Recalls EPIONE Device Due to Internal Component Corrosion
Quantum Surgical recalls 2 units of the EPIONE device v1.0.2 because rust has developed on the central axis component of the Needle Guide product. These units were distributed in Florida.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall. Although no injuries or illnesses have been reported, rust on the central axis component of a precision stereotactic guidance device presents a material risk of malfunction that could impact the accuracy and safety of CT-guided percutaneous procedures.
Plain-English summary
The EPIONE device v1.0.2 is a stereotactic accessory device designed to assist in the planning and manual advancement of instruments, as well as verification of instrument position during computed tomography (CT) guided percutaneous procedures. The device enables monitoring of respiratory levels and verification of patient position prior to instrument advancement.
Quantum Surgical has identified rust developing on the central axis component inside the Needle Guide product (product number 02-0027). Rust on this internal component could potentially affect the accuracy and reliability of the device's guidance function.
Two units of the EPIONE device v1.0.2 are affected, identified by serial numbers 0321015 and 0321017. These units were distributed in Florida.
The recalled product
- 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. Du
- Manufacturer
- QUANTUM SURGICAL SAS
- Category
- Medical Device — Surgical Device
- Hazard
- corrosion
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 37603054002NGXL
- serial numbers: 0321015 and 0321017
Distribution
Distributed nationwide across the United States.
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