Severity
Moderate
ModerateClass IICompleted
FDA Devices recall · Reported October 16, 2024
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
Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Quantum Surgical Sas recalled The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to … - a moderate-severity action.
The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to … was recalled by Quantum Surgical Sas in October 16, 2024. Reason: Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product nu…. Check the official notice for the remedy. Verify recall #Z-0037-2025 with the FDA Devices before acting.
The recall
Quantum Surgical Sas issued this moderate-severity FDA Devices recall-Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product nu….
- Moderate
- severity level
- 2 units
- affected scope
- Class II
- classification
- October 16, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0037-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0037-2025) was formally reported on October 16, 2024, with the manufacturer initiating the action on August 5, 2024. It is classified under Moderate severity (Class II), with a current status of Completed. Quantum Surgical Sas is listed as the recalling firm, operating out of montpellier. Federal records list the affected scope as 2 units.
The documented reason for this recall is: Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust. Distribution data in the federal record shows the product reached: US Nationwide distribution in the state of FL.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2 units
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Completed |
| Recall number | Z-0037-2025 |
| Date reported | October 16, 2024 |
| Date initiated | August 5, 2024 |
| Recalling firm | Quantum Surgical Sas |
| Firm location | montpellier |
| Affected scope | 2 units |
| Distribution | US Nationwide distribution in the state of FL. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0037-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Quantum Surgical Sas. Units affected: 2 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 16, 2024. Severity: Moderate. Recall number: Z-0037-2025.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the state of FL..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0037-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 16, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.