The Recall Desk

Manufacturer

QUANTUM SURGICAL SAS

2 recalls in our database name QUANTUM SURGICAL SAS as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2025-06-18

Of the 2 recalls from QUANTUM SURGICAL SAS we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • HighFDA (Devices)·Z-1927-2025·2025-06-18

    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.

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0037-2025·2024-10-16

    FDA Recalls EPIONE Device Due to Internal Component Corrosion

    Quantum Surgical recalls 2 units of the EPIONE device v1.0.2 because rust has developed on the central axis component of the Needle Guide product. These units were distributed in Florida.

    Product
    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. Du
    Category
    Medical Device
    Distribution
    Distributed nationwide