FDA Device Recall Z-0037-2025: Recall Record

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0037-2025.

Recall Res Number

Z-0037-2025

Recalling Firm / Manufacturer

N/A

FEI Number

3023140882

Recall Status

Completed

Recall Classification

N/A

Date Initiated

2024-08-05

Date Posted

2024-10-09

Date Terminated

N/A

Product Code

JAK

Event Number

95194

Product Quantity

2 units

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.

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.

Action Details 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.

Distribution Pattern US Nationwide distribution in the state of FL.

Code Information / Serial Numbers UDI/DI 37603054002NGXL, serial numbers: 0321015 and 0321017

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Medical Device Recall: Z-0037-2025

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer