Quantum Surgical recalls EPIONE v1.0.2 devices with serial numbers 0321015 and 0321017 due to potential rust in the central axis component. This may affect medical procedures requiring precise instrument placement.
Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.
Quantum Surgical is recalling specific versions of their EPIONE device because a part inside the Needle Guide can rust. This could cause issues during medical procedures where precise instrument placement is needed.
The central axis component in the Needle Guide can rust, which might cause the device to malfunction during medical procedures. This could lead to inaccurate instrument placement if the device is used for planning and guiding surgical steps.
Medical professionals using the EPIONE device v1.0.2 with serial numbers 0321015 and 0321017 are most at risk. The recall affects a small number of devices sold for surgical planning and guidance.
Check for the EPIONE device v1.0.2 with serial numbers 0321015 or 0321017. The device is used in surgical planning and guidance for CT procedures.
Verify the serial number on your EPIONE device to see if it matches 0321015 or 0321017.
The EPIONE device is a stereotactic accessory used to assist in planning and guiding surgical instruments during CT procedures.
Quantum Surgical has identified that the central axis component in the Needle Guide can rust, which might affect device function during medical procedures.
Check the serial number on your EPIONE device; affected units have serial numbers 0321015 or 0321017.
We’ve drafted a message you can send Quantum Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0037-2025 — Quantum Surgical Quantum Surgical Hello, I own a Quantum Surgical that is covered by recall Z-0037-2025 from Quantum Surgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
