# FDA recall Z-1927-2025

> **QUANTUM SURGICAL SAS** · Class II · device recall initiated 2025-05-23.

## 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 (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.

## Distribution

Worldwide distribution - U.S. Nationwide distribution in the states of FL,IL, IN, and TX. The countries of France, Germany and United Kingdom.

## Key facts

- **Recall number:** Z-1927-2025
- **Recalling firm:** QUANTUM SURGICAL SAS
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-23
- **Report date:** 2025-06-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** montpellier, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1927-2025

## Citation

> AI Analytics. FDA recall Z-1927-2025. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1927-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*