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Medical robotics · recall

FDA Class II recall: EPIONE Model 30-0001

S3 · 23 May 2025 · Quantum Surgical

Record

CompanyQuantum Surgical
IndustryMedical robotics
Type(s)recall
Date23 May 2025 (day precision)
Time of daynot documented
Locationno physical site (recall / fleet-wide / aggregate record)
Severity (recall, enforcement, or fleet-wide fault)
ScaleEPIONE Model 30-0001
Confidencehigh
Verified flagYes - independently re-checked against the cited source

Summary

FDA enforcement record (Class II, recall Z-1927-2025): Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.

Primary source

openFDA enforcement

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

Supporting source rows (1)
DateSupporting source rowPublisherLink
23 May 2025 FDA Class II recall: EPIONE Model 30-0001 openFDA enforcement openFDA enforcement

Quantum Surgical other incidents timeline

Medical robotics context

recall context

Quantum Surgical industry position

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