Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported June 18, 2025
EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory 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 ablation procedures in the abdomen, performed by physicians trained for CT procedures and performed under general anaesthesia with rigid straight instruments such as needles and probes of diamet
Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Quantum Surgical Sas recalled EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user control… - a moderate-severity action.
EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user control… was recalled by Quantum Surgical Sas in June 18, 2025. Reason: Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined b…. Check the official notice for the remedy. Verify recall #Z-1927-2025 with the FDA Devices before acting.
The recall
Quantum Surgical Sas issued this moderate-severity FDA Devices recall-Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined b….
- Moderate
- severity level
- 4 units
- affected scope
- Class II
- classification
- June 18, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1927-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1927-2025) was formally reported on June 18, 2025, with the manufacturer initiating the action on May 23, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Quantum Surgical Sas is listed as the recalling firm, operating out of montpellier. Federal records list the affected scope as 4 units in U.S..
The documented reason for this recall is: Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user. Distribution data in the federal record shows the product reached: Worldwide distribution - U.S. Nationwide distribution in the states of FL,IL, IN, and TX. The countries of France, Germany and United Kingdom.. 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
4 units in U.S.
Related Recalls
6
3 from same agency
Product description
EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory 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 ablation procedures in the abdomen, performed by physicians trained for CT procedures and performed under general anaesthesia with rigid straight instruments such as needles and probes of diameters ranging from 11G to 19G.
Reason for recall
Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1927-2025 |
| Date reported | June 18, 2025 |
| Date initiated | May 23, 2025 |
| Recalling firm | Quantum Surgical Sas |
| Firm location | montpellier |
| Affected scope | 4 units in U.S. |
| Distribution | Worldwide distribution - U.S. Nationwide distribution in the states of FL,IL, IN, and TX. The countries of France, Germany and United Kingdom. |
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-1927-2025) 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? ▼
EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory 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 ablation procedures in the abdomen, performed by physicians trained for CT procedures and performed under general anaesthesia with rigid straight instruments such as needles and probes of diameters ranging from 11G to 19G.. Recalled by Quantum Surgical Sas. Units affected: 4 units in U.S..
Why was this product recalled? ▼
Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 18, 2025. Severity: Moderate. Recall number: Z-1927-2025.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of FL,IL, IN, and TX. The countries of France, Germany and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1927-2025) 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 June 18, 2025. 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.