The EPIONE device v1.0.2 is a user controlled, stereotactic… recallZ-0037-2025 · Quantum Surgical Sas · initiated Aug 5, 2024
Class II Completed All recalls posted in October 2024
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Quantum Surgical Sas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0037-2025
- Recall class
- Class II
- Status
- Completed
- Initiated by the company
- Aug 5, 2024
- Posted by the FDA
- Oct 9, 2024
- Recalling firm
- Quantum Surgical Sas
- Quantity
- 2 units
- Product code
- JAK
- FDA submissions
- K223758
- Distribution
- US Nationwide distribution in the state of FL.
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.
Code information (models, lots, serial numbers)
UDI/DI 37603054002NGXL, serial numbers: 0321015 and 0321017
Other devices under the same FDA submission
1 device cleared under K223758 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- EPIONE 30-0001 v1.0.2Quantum Surgical · System, X-Ray, Tomography, Computed1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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