RobotRisk Autonomous Systems Incident & Risk Register
RobotRiskVirtual Incision › 23 Apr 2025

FDA Class II recall: MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical sur

S3 · 23 Apr 2025 · Virtual Incision

Record

CompanyVirtual Incision
IndustryMedical robotics
Type(s)recall
Date23 Apr 2025 (day precision)
Time of daynot documented
Locationno physical site (recall / fleet-wide / aggregate record)
Severity (recall, enforcement, or fleet-wide fault)
ScaleMIRA SURGICAL SYSTEM, Table mounted miniaturized electromech
Confidencehigh
Verified flagYes - independently re-checked against the cited source

Summary

FDA enforcement record (Class II, recall Z-1905-2025): The MIRA Surgical System Software Version 4.0.3 loaded on the Surgeon Control Console may have the potential to exhibit interrupted motion on the display screen, caused by a software latency between the movement of the hand controllers and the movement of the Surgical Minibot arm

Primary source

openFDA enforcement

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

Supporting source rows (1)
DateSupporting source rowPublisherLink
23 Apr 2025 FDA Class II recall: MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical sur openFDA enforcement openFDA enforcement

Medical robotics context

recall context

Virtual Incision industry position

Related incidents

Other Virtual Incision entries

Report a correction

Open a prefilled GitHub issue

Also from Critical Systems Analysis: CSA - functional safety engineering · Company directory · FSTalent - functional safety jobs