[pending] EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereo
Pending LLM rewrite. Source: FDA_DEVICE Z-1927-2025.
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: Pending LLM scoring against the rubric.
Plain-English summary
Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
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 — Devices
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.
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