{"id":"a312391b-cbf5-4d04-a2c3-8ea785108ee7","slug":"asensus-senhance-uncontrolled-arm-motion-recall-2024","kind":"recall","headline":"Asensus recalls Senhance Surgical System (Class I) over uncontrolled robotic-arm motion","summary":"Asensus Surgical recalled the Senhance Surgical System after the Laparoscope Instrument Actuator could continue rotating after the surgeon disengaged teleoperation, an uncontrolled robotic-arm motion with potential for critical-tissue trauma. This is the first Senhance recall recorded here. Class I, 21 units. Source: FDA Class I device recall Z-0170-2024, accessdata.fda.gov; FDA recall notice fda.gov/medical-devices.","occurredAt":"2023-09-15T00:00:00.000Z","reviewStatus":"unreviewed","modelId":null,"deploymentId":null,"companyId":"a3a097cb-a5db-4ffd-b421-5eb14335dbcf","aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"critical","rootCauseCategory":null,"rootCauseDetail":null,"affectedUnitsCount":21,"affectedUnitsBasis":"exact","remediationStatus":null,"regulatoryAction":"recall_ordered","regulatoryBody":"FDA","propertyDamageEstimateUsd":null,"damageEstimateBasis":null,"bodilyInjurySeverity":null,"fatalityCount":null,"lossCostClass":null,"sourceQualityTier":2,"createdAt":"2026-06-27T10:59:23.736Z","updatedAt":"2026-06-27T10:59:23.736Z","model":null,"deployment":null,"company":{"id":"a3a097cb-a5db-4ffd-b421-5eb14335dbcf","name":"Asensus Surgical","slug":"asensus-surgical","description":"Asensus Surgical is an American surgical robotics company based in Durham, North Carolina, developing the Senhance robotic surgical system for minimally invasive abdominal surgery, with AI-powered surgical intelligence and augmented reality visualization.","status":"acquired by Karl Storz (Aug 2024; ~$95M; delisted)","founded":2006,"hq":"Durham, NC","fundingTotal":null,"type":"both","reviewStatus":"reviewed","sources":[{"url":"https://www.globenewswire.com/news-release/2024/08/22/asensus-surgical-karl-storz-closing","title":"Asensus Surgical: closing of acquisition by Karl Storz ($0.35/sh, ~$95M; delisted; LUNA not cleared)","sourceName":"Asensus (GlobeNewswire)"},{"url":"https://www.massdevice.com/asensus-surgical-karl-storz-acquisition/","title":"Asensus agrees to be acquired by Karl Storz (~$95M, 67% premium)","sourceName":"MassDevice"},{"url":"https://www.urologytimes.com/view/transenterix-senhance-fda-clearance","title":"TransEnterix (Asensus) Senhance US FDA 510(k) clearance (Oct 2017)","sourceName":"Urology Times"},{"url":"https://www.therobotreport.com/karl-storz-closes-acquisition-of-asensus-surgical/","title":"Karl Storz closes acquisition of Asensus Surgical (Aug 2024)","sourceName":"The Robot Report"}],"keyFacts":[{"label":"Product","value":"Senhance laparoscopic robot (FDA 510(k) Oct 2017); LUNA next-gen (uncleared)."},{"label":"Acquisition","value":"Karl Storz, closed Aug 22 2024, $0.35/sh ~$95M; delisted."},{"label":"Former name","value":"TransEnterix"}],"aliases":["Asensus","TransEnterix","Senhance","Karl Storz"],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"createdAt":"2026-06-03T20:12:49.932Z","updatedAt":"2026-07-03T17:30:06.643Z"},"derived":{"status":"active"},"sources":[],"responses":[],"statusEvents":[],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/asensus-senhance-uncontrolled-arm-motion-recall-2024","url":"https://registry.deploy.report/incidents/asensus-senhance-uncontrolled-arm-motion-recall-2024","headline":"Asensus recalls Senhance Surgical System (Class I) over uncontrolled robotic-arm motion","description":"Asensus Surgical recalled the Senhance Surgical System after the Laparoscope Instrument Actuator could continue rotating after the surgeon disengaged teleoperation, an uncontrolled robotic-arm motion with potential for critical-tissue trauma. This is the first Senhance recall recorded here. Class I, 21 units. Source: FDA Class I device recall Z-0170-2024, accessdata.fda.gov; FDA recall notice fda.gov/medical-devices.","identifier":"a312391b-cbf5-4d04-a2c3-8ea785108ee7","datePublished":"2023-09-15T00:00:00.000Z","articleSection":"recall","publisher":{"@id":"https://deploy.report/#organization"},"author":{"@id":"https://deploy.report/#organization"}},"framework_metadata":{"framework_schema_version":"0.1.0","verification_status":"unreviewed","maturity_stage":null,"lifecycle_state":null,"architectural_position":{"cohort":null,"sub_cohorts":[]},"within_cohort_verified_vs_claimed_pair":null,"cap_flags":[],"verification_depth":{"sources_count":0,"primary_source_types":[]}}}