EPIONE Device v1.0.2 (Unknown) – Component Rust Risk (2024)
A component inside the Needle Guide product may be subject to rust.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Lot Codes / Batch Numbers
UDI/DI 37603054002NGXL, serial numbers: 0321015 and 0321017
Products Sold
UDI/DI 37603054002NGXL, serial numbers: 0321015 and 0321017
A medical device manufacturer is recalling The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in t due to Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026