QUANTUM SURGICAL SAS recall records

1 reported ongoing

2 records in this archive. Latest source date May 23, 2025.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

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...

Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.

Class IIReported ongoing

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

Official source for EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereot...
FDA device enforcement

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 ...

Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.

Class IIReported completed

Distribution: US Nationwide distribution in the state of FL.

Official source for The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist i...

Reasons in these listed records

  • Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
  • Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.

These examples come from this result page and are not a ranking of every recall reason.

Checking QUANTUM SURGICAL SAS

Is there a recall on quantum surgical sas right now?

This archive contains 2 records, including 1 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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