{"id":"e6425590-be49-4ab6-994b-0ff020bae90b","slug":"asensus-senhance-uncontrolled-arm-recall-2023","kind":"recall","headline":"Asensus Senhance Class I recall: software malfunction caused uncontrolled arm motion after disengaging teleop","summary":"Class I recall (Sep 15 2023): a software malfunction caused uncontrolled arm motion of the laparoscope instrument actuator, which rotated continuously in one direction after the surgeon disengaged teleoperation (critical-tissue-trauma risk; emergency stop available as mitigation). 5 US devices; cease-use until software updated to v2.7.5. No patient harm reported.","occurredAt":"2023-09-15T12:00:00.000Z","reviewStatus":"reviewed","modelId":"abadf566-b528-4b44-be3e-418ca078e920","deploymentId":null,"companyId":"a3a097cb-a5db-4ffd-b421-5eb14335dbcf","aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"critical","rootCauseCategory":"software_defect","rootCauseDetail":"Software malfunction: laparoscope instrument actuator rotated continuously after teleoperation was disengaged.","affectedUnitsCount":5,"affectedUnitsBasis":"exact","remediationStatus":"remediated","regulatoryAction":"recall_ordered","regulatoryBody":"FDA","propertyDamageEstimateUsd":null,"damageEstimateBasis":null,"bodilyInjurySeverity":null,"fatalityCount":null,"lossCostClass":null,"sourceQualityTier":null,"oshaRecordable":null,"oshaCaseNumber":null,"rootCauseDisclosed":null,"publicDisclosureDate":null,"insuranceClaimPublic":null,"createdAt":"2026-06-04T21:06:22.101Z","updatedAt":"2026-06-24T23:33:41.852Z","model":{"id":"abadf566-b528-4b44-be3e-418ca078e920","companyId":"a3a097cb-a5db-4ffd-b421-5eb14335dbcf","modelName":"Senhance","slug":"asensus-senhance","description":"Asensus Surgical, formerly TransEnterix and based in Durham, North Carolina, was a public company on the NYSE American as ASXC that made the Senhance multi-port laparoscopic robotic system, FDA-cleared via 510(k) in October 2017 with subsequent instrument and indication clearances, making Senhance a genuinely cleared if relatively low-volume commercial product. The headline current-state fact is that Karl Storz acquired the company, closing on August 22, 2024 at $0.35 per share for about $95 million, a roughly 67 percent premium, with the stock ceasing to trade on the NYSE American at close, leaving Asensus a private Karl Storz subsidiary; this is the canonical example of a large medtech company absorbing a struggling robotics startup for a fraction of its historic enterprise value. The registry records Senhance at commercial maturity with an active lifecycle, since it remains a cleared product line continuing under Karl Storz, while the company status is recorded as acquired. The company's next-generation LUNA system, unveiled in February 2023 with claimed real-time clinical intelligence and cloud machine learning, was not FDA-submitted, not cleared, and not for sale as of the August 2024 close, so LUNA is recorded at research maturity, with a 2025 FDA target that is unverified as met and a current status under private ownership that is not publicly traceable. On AI substance the cleared digital-surgery features are machine-vision and digital-laparoscopy assists that are real but incremental rather than autonomy, and the Performance-Guided Surgery framing was oversold relative to what is cleared.","formFactor":"surgical","industryVertical":"healthcare","environment":"indoor","maturityStage":"commercial","lifecycleState":"active","supersededByModelId":null,"specs":{"notes":[{"label":"Verified","value":"Asensus Surgical (formerly TransEnterix; Durham NC; was NYSE American: ASXC) made the Senhance laparoscopic robot, FDA-cleared via 510(k) in Oct 2017 with subsequent clearances/indication expansions. Senhance is a genuinely cleared, commercial (if low-volume) product."},{"label":"Current status: ACQUIRED by Karl Storz (the headline)","value":"Karl Storz acquired 100% of Asensus, closing Aug 22 2024 at $0.35/share (~$95M total, ~67% premium); the stock ceased trading on NYSE American at close (delisted; now a private Karl Storz subsidiary). The canonical big-medtech-acquires-struggling-robotics-startup datapoint: a former public-market name sold for a fraction of its historic enterprise value. maturityStage=commercial (Senhance is cleared + still a product line); company status=acquired; lifecycleState=active (Senhance line continues under Karl Storz)."},{"label":"LUNA = research","value":"The next-gen LUNA (real-time 'clinical intelligence' + cloud ML) was NOT FDA-submitted / NOT cleared / NOT for sale as of the Aug 2024 close. Karl Storz had targeted 2025 FDA - that target is unverified as met. LUNA = research-tier; current status under private-owner Karl Storz is not publicly traceable (cap-flag)."},{"label":"AI-substance + claimed-not-verified","value":"Cleared 'digital surgery' substance = machine-vision/digital-laparoscopy assists (real but incremental, not autonomy); 'Performance-Guided Surgery' framing oversold vs what's cleared. NOT verified: LUNA FDA submission/clearance ever occurring; current Senhance installed-unit count (Karl Storz private); whether Senhance is actively commercialized vs wound down under Karl Storz."}],"products":"Senhance: FDA-cleared multi-port laparoscopic robotic system (initial 510(k) Oct 2017 as TransEnterix; later 3mm instruments, ultrasonic, indication expansions, machine-vision clearance). LUNA: next-gen system (unveiled Feb 2023) with claimed real-time clinical intelligence + cloud ML; NOT FDA-submitted/cleared, NOT for sale.","formFactor":"surgical (multi-port laparoscopic teleoperated robotic system with machine-vision/digital-laparoscopy assists)","fda_clearance":"October 2017","clearance_body":"FDA","procedure_types":"multi-port laparoscopic"},"manufacturerSerial":null,"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"}],"aliases":["Senhance","Asensus Senhance","TransEnterix Senhance","LUNA"],"collisionRisk":"low","reviewNote":null,"manufacturerTermForTeleop":null,"keyFacts":[{"label":"Acquisition price","value":"$0.35 per share (~$95 million total)"},{"label":"Acquisition close date","value":"August 22, 2024"},{"label":"FDA clearance date","value":"October 2017"},{"label":"LUNA unveiling date","value":"February 2023"},{"label":"LUNA FDA target","value":"2025"}],"createdAt":"2026-06-03T20:12:50.702Z","updatedAt":"2026-07-12T04:24:54.291Z","unitsInFieldClaimed":null,"unitsInFieldVerified":null,"unitsManufacturedClaimed":null,"unitsManufacturedVerified":null,"unitsAsOf":null,"unitsSource":null,"salesModel":null,"priceUndisclosedSince":null,"autonomyClass":null,"autonomyStatement":null,"autonomyStatementSource":null,"demoForensics":null,"exportControlClass":null,"minCommitment":null,"warrantyTerms":null,"serviceModel":null,"productionRateClaimed":null,"productionRateEvidenced":null,"teleopRatioDisclosed":null,"interventionRateDisclosed":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","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,"createdAt":"2026-06-03T20:12:49.932Z","updatedAt":"2026-07-06T06:44:48.490Z"},"derived":{"status":"active"},"sources":[{"id":"0e86e5a4-3e85-4ba1-921b-001d117f208c","incidentId":"e6425590-be49-4ab6-994b-0ff020bae90b","url":"https://www.therobotreport.com/fda-recalls-asensus-surgical-robot-due-to-unintended-movement/","label":"The Robot Report","publishedAt":null,"notes":null,"title":null,"sourceName":null,"mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-06-04T21:06:22.101Z","updatedAt":"2026-06-04T21:06:22.101Z"}],"responses":[],"statusEvents":[],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/asensus-senhance-uncontrolled-arm-recall-2023","url":"https://registry.deploy.report/incidents/asensus-senhance-uncontrolled-arm-recall-2023","headline":"Asensus Senhance Class I recall: software malfunction caused uncontrolled arm motion after disengaging teleop","description":"Class I recall (Sep 15 2023): a software malfunction caused uncontrolled arm motion of the laparoscope instrument actuator, which rotated continuously in one direction after the surgeon disengaged teleoperation (critical-tissue-trauma risk; emergency stop available as mitigation). 5 US devices; cease-use until software updated to v2.7.5. No patient harm reported.","identifier":"e6425590-be49-4ab6-994b-0ff020bae90b","datePublished":"2023-09-15T12:00:00.000Z","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":["secondary-trade-publication"]}}}