RobotRisk Autonomous Systems Incident & Risk Register
RobotRisk › Asensus Surgical › 15 Sep 2023
Medical robotics · recall

Class I recall of Senhance surgical robot over unintended arm movement

S3 · 15 Sep 2023 · Asensus Surgical

Record

CompanyAsensus Surgical
IndustryMedical robotics
Type(s)recall
Date15 Sep 2023 (day precision)
Time of daynot documented
Locationno physical site (recall / fleet-wide / aggregate record)
Severity (recall, enforcement, or fleet-wide fault)
Scale5 devices in the US, distributed April-September 2023
Confidencehigh
Verified flagCited source on file; not independently re-verified

Summary

FDA classified Asensus Surgical's recall of the Senhance Surgical System as Class I after malfunctions caused uncontrolled, continuous rotation of the laparoscope instrument actuator arm even after the surgeon disengaged teleoperation, creating potential for critical tissue trauma; Asensus reported no patient harm to date and instructed customers to stop use until a software update (v2.7.5) was applied.

Primary source

FDA

Publisher: FDA · Retrieved: 2026-09-16

Supporting source rows (1)
DateSupporting source rowPublisherLink
15 Sep 2023 Class I recall of Senhance surgical robot over unintended arm movement FDA FDA

Medical robotics context

recall context

Asensus Surgical industry position

Related incidents

SevDateCompanyIncident
S5 11 Mar 2026 Intuitive Surgical Class I recall of da Vinci SureForm stapler reloads after patient death
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
S4 25 Mar 2016 Monteris Medical FDA Class I recall: NeuroBlate System SideFire Select
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 May 2025 Quantum Surgical FDA Class II recall: EPIONE Model 30-0001
S3 23 Apr 2025 Virtual Incision FDA Class II recall: MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical sur

Other Asensus Surgical entries

Report a correction

Open a prefilled GitHub issue

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