{"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":"reviewed","modelId":null,"deploymentId":null,"companyId":"a3a097cb-a5db-4ffd-b421-5eb14335dbcf","dataCenterId":null,"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,"oshaRecordable":null,"oshaCaseNumber":null,"rootCauseDisclosed":null,"publicDisclosureDate":null,"insuranceClaimPublic":null,"formFactor":null,"latitude":null,"longitude":null,"autonomyClass":null,"legalOutcomeClass":"unknown","createdAt":"2026-06-27T10:59:23.736Z","updatedAt":"2026-08-09T05:24:01.599Z","model":null,"deployment":null,"company":{"id":"a3a097cb-a5db-4ffd-b421-5eb14335dbcf","name":"Asensus Surgical","slug":"asensus-surgical","description":"Asensus Surgical was a Durham, NC-based surgical robotics company that developed the Senhance Surgical System, a digital laparoscopic platform that received FDA 510(k) clearance. The company also developed the Luna surgical robot platform. Asensus was acquired by KARL STORZ in 2024 for 35 cents per share, which retired the Senhance platform, discontinued Luna development, and sunset the Asensus brand to create a surgical robotics hub for Performance-Guided Surgery.","status":"acquired by Karl Storz (Aug 2024; ~$95M; delisted)","founded":2006,"hq":"Durham, NC","hqLat":35.996653,"hqLng":-78.9018053,"hqGeocodedAt":"2026-08-05T14:20:14.253Z","hqAddress":null,"hqPrecision":null,"website":"asensus.com","fundingTotal":null,"type":"both","reviewStatus":"reviewed","lifecycleState":"active","supersededByCompanyId":null,"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 Surgical System (FDA 510(k) cleared)"},{"label":"Acquisition","value":"Karl Storz, closed Aug 22 2024, $0.35/sh ~$95M; delisted."},{"label":"Former name","value":"TransEnterix"},{"label":"Luna platform","value":"Discontinued after KARL STORZ acquisition"}],"aliases":["Asensus","TransEnterix","Senhance","Karl Storz"],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"factoryLocations":null,"manufacturingCapacity":null,"orgType":null,"burnSignal":null,"litigationEvents":null,"insurancePostureDisclosed":null,"unitEconomicsDisclosed":null,"tickerSymbol":null,"stockExchange":null,"secCik":null,"revenueUsd":null,"revenueBasis":null,"revenueAsOf":null,"employeeCount":null,"employeeCountBasis":null,"employeeCountAsOf":null,"marketCapUsd":null,"marketCapAsOf":null,"marketCapSource":null,"createdAt":"2026-06-03T20:12:49.932Z","updatedAt":"2026-08-05T14:35:19.875Z"},"derived":{"status":"active"},"sources":[{"id":"a00c6a54-7323-4096-a74d-764d0675a3eb","incidentId":"a312391b-cbf5-4d04-a2c3-8ea785108ee7","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?start_search=1&firmlegalnam=Asensus&postdatefrom=01/01/2023&postdateto=12/31/2026","label":null,"publishedAt":null,"notes":null,"title":"FDA Recalls — Asensus Surgical","sourceName":"FDA","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-22T01:56:25.056Z","updatedAt":"2026-07-22T01:56:25.056Z"}],"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":"verified","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":1,"primary_source_types":["primary-fda-database"]}}}