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Recall Observatory FDA recall evidence

Device 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.

Z-0037-2025

August 05, 2024

Class II

Product summary

Firm
QUANTUM SURGICAL SAS
Event
Event 95194
Status
Completed
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-0037-2025

Official wording

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.

Code information: UDI/DI 37603054002NGXL, serial numbers: 0321015 and 0321017

Distribution pattern: US Nationwide distribution in the state of FL.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.