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.
FDA Recall Z-0037-2025 · Posted 2024-10-09
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Recalling FirmQUANTUM SURGICAL SAS
Recall StatusCompleted
Product CodeJAK
Date Initiated2024-08-05
Product Quantity2 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.
Firm Action
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.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution in the state of FL.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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