The Recall Desk
HighFDA (Devices)·Z-1927-2025·Announced 2025-06-18

EPIONE Stereotactic Device Software Bug Poses Instrument Guidance Risk

The EPIONE Model 30-0001 stereotactic device is recalled due to a software bug that may cause the robotic arm to incorrectly guide surgical instruments during CT-guided ablation procedures. Four units have been distributed in the U.S.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving a risk-of-harm medical device (incorrect robotic arm guidance during surgical ablation procedures) where the source text does not explicitly report any illnesses or injuries. Per the rubric, such cases are scored as High (3).

Plain-English summary

QUANTUM SURGICAL SAS is recalling the EPIONE Model 30-0001 stereotactic device (UDI-DI code: 03760305400031, Software Version 1.0.6.1) due to a software bug that may cause the robotic arm to incorrectly guide the instrument compared to the planning defined by the user.

The EPIONE 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. The procedures are performed by physicians trained for CT procedures and performed under general anesthesia with rigid straight instruments such as needles and probes of diameters ranging from 11G to 19G.

In the U.S., four units have been distributed to Florida, Illinois, Indiana, and Texas (serial numbers: 0322002, 0323006, 0323003, and 0324001). International distribution occurred in France, Germany, and the United Kingdom.

Users should contact QUANTUM SURGICAL SAS regarding this recall and consult with the manufacturer regarding appropriate remediation steps.

The recalled product

Product
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
Manufacturer
QUANTUM SURGICAL SAS
Category
Medical Device — Surgical / Stereotactic Navigation
Hazard
  • software-bug
  • instrument-guidance-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • 0323006
  • 0323003 and 0324001

Distribution

Distributed nationwide across the United States.

Related recalls

Same category