RobotRisk › Quantum Surgical › 05 Aug 2024

FDA Class II recall: The EPIONE device v1.0.2 is a user controlled, stereotactic accessory

S3 · 05 Aug 2024 · Quantum Surgical

Record

Company	Quantum Surgical
Industry	Medical robotics
Type(s)	recall
Date	05 Aug 2024 (day precision)
Time of day	not documented
Location	no physical site (recall / fleet-wide / aggregate record)
Severity	(recall, enforcement, or fleet-wide fault)
Scale	The EPIONE device v1.0.2 is a user controlled, stereotactic
Confidence	high
Verified flag	Yes - independently re-checked against the cited source

Summary

FDA enforcement record (Class II, recall Z-0037-2025): Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.

Primary source

openFDA enforcement

Publisher: openFDA enforcement · Retrieved: 2026-09-16

Supporting source rows (1)

Date	Supporting source row	Publisher	Link
05 Aug 2024	FDA Class II recall: The EPIONE device v1.0.2 is a user controlled, stereotactic accessory	openFDA enforcement	openFDA enforcement

Quantum Surgical other incidents timeline

Medical robotics context

recall context

Quantum Surgical industry position

Related incidents

Sev	Date	Company	Incident
S3	23 May 2025	Quantum Surgical	FDA Class II recall: EPIONE Model 30-0001
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S4	25 Mar 2026	Omnicell	FDA Class I recall: Rolls of label stock used with the Omnicell i.v.Station.
S4	~Oct 2017	Monteris Medical	FDA Class I recall: MONTERIS MEDICAL NEUROBLATE SYSTEM, used for
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S3	21 Jan 2026	Auris Health (J&J MedTech)	FDA Class II recall: MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-0
S3	12 Sep 2025	Noah Medical	FDA Class II recall: Brand Name: Galaxy System
S3	23 Apr 2025	Virtual Incision	FDA Class II recall: MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical sur

Other Quantum Surgical entries

23 May 2025 - FDA Class II recall: EPIONE Model 30-0001

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