{"id":"dca66785-bf0e-47f6-8b40-1ccda41ce097","slug":"intuitive-davinci5-ui-crash-monitor-loss-recall-2025","kind":"recall","headline":"Intuitive Surgical recalls 12 da Vinci 5 systems over UI application crash and loss of monitor display","summary":"FDA Class 2 recall Z-1428-2026 (firm-initiated Nov 17 2025; posted Feb 18 2026): Software version P1.2.1 caused an increase in Error 48306 events on da Vinci 5 systems in dual console configuration, causing User Interface application crashes and loss of interaction at the affected node. External monitor and tower monitor UI may not display (live endoscopic video still displayed). FDA-determined cause: Software Design Change. 12 units in commerce across 6 US states. Corrective patch P1.2.2 in development.","occurredAt":"2025-11-17T12:00:00.000Z","reviewStatus":"unreviewed","modelId":"45105ba4-1c1f-4121-9ad4-bb912db1dcfc","deploymentId":null,"companyId":null,"aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"moderate","rootCauseCategory":"software_defect","rootCauseDetail":"Software P1.2.1 causes UI application crashes (Error 48306) in dual console config; loss of external/tower monitor UI, though live video remains.","affectedUnitsCount":12,"affectedUnitsBasis":"exact","remediationStatus":"in_progress","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,"formFactor":null,"latitude":{"s":1,"e":1,"d":[36,2048000]},"longitude":{"s":1,"e":2,"d":[138,2529000]},"autonomyClass":null,"legalOutcomeClass":"unknown","createdAt":"2026-07-22T00:32:22.897Z","updatedAt":"2026-07-22T00:32:22.897Z","model":{"id":"45105ba4-1c1f-4121-9ad4-bb912db1dcfc","companyId":"e5127536-0ff2-4f0e-8488-64994cb2ffc7","modelName":"da Vinci (and Ion)","slug":"intuitive-da-vinci","description":"Intuitive Surgical (NASDAQ: ISRG; founded 1995, Sunnyvale, California) is the dominant incumbent and verified gold standard of surgical robotics. Its da Vinci platform spans the multi-port X and Xi systems, the SP single-port system, and the fifth-generation da Vinci 5, which the FDA cleared via 510(k) on March 14, 2024 with a headline Force Feedback sensing feature, alongside the Ion endoluminal robotic bronchoscopy system cleared in February 2019. As of its SEC Form 10-Q for the quarter ended March 31, 2026, the verified installed base was 11,395 da Vinci systems, up 12 percent year over year and including 1,464 da Vinci 5 units, plus 1,041 Ion systems, up 22 percent, with worldwide procedures growing about 17 percent. Surgical robotics sits in the registry as a deliberate axis-extension: physical AI operating in the medical regulatory regime, where FDA clearance is the verified gating event for maturity, and Intuitive clears it across multiple platforms and generations, placing it at production maturity. On AI substance, da Vinci is a master-slave teleoperated system with shipped analytics-grade AI such as Case Insights and machine-vision interface features, and Force Feedback is a shipped sensing feature rather than autonomy; autonomous suturing and tissue manipulation via vision-language models are research demonstrations on da Vinci hardware, not shipped features, and the 4,000-mile telesurgery demonstration is investigational. The widely cited 43-percent-less-force figure is preclinical and marketing-sourced rather than an outcomes-verified clinical result.","formFactor":"surgical","industryVertical":"healthcare","environment":"indoor","maturityStage":"production","lifecycleState":"active","supersededByModelId":null,"specs":{"dof":7,"notes":[{"label":"Verified (production anchor)","value":"Intuitive Surgical (NASDAQ: ISRG; founded 1995, Sunnyvale CA) is the dominant incumbent and the verified gold standard. VERIFIED installed base (SEC 10-Q, 3/31/2026): 11,395 da Vinci systems (+12% YoY), of which 1,464 are da Vinci 5; plus 1,041 Ion systems (+22% YoY). Q1 2026 procedures +17% worldwide; 431 da Vinci placed (232 of them da Vinci 5). da Vinci 5 FDA-cleared Mar 14 2024; Ion FDA-cleared Feb 2019."},{"label":"Axis-extension framing","value":"Surgical robotics is physical AI operating in the MEDICAL regulatory regime. FDA clearance is the verified gating event for maturity. Intuitive clears it across multiple platforms + generations -> production."},{"label":"AI-substance: teleop baseline + shipped analytics AI; autonomy demo-only","value":"da Vinci is master-slave teleoperated. SHIPPED AI: Case Insights (AI analysis of system/kinematics/video for surgeon performance) and machine-vision interface features; Force Feedback is a shipped sensing feature (not autonomy). Autonomous suturing/tissue-lifting via VLMs (Johns Hopkins/Stanford) are RESEARCH demonstrations on da Vinci hardware, NOT shipped. 4,000-mile telesurgery is investigational/in-development."},{"label":"Claimed but NOT verified","value":"'43% less force' is a preclinical/marketing figure, not an outcomes-verified clinical result. The 1,464 da Vinci 5 subfigure is company-reported (corroborated, model-level breakout)."}],"products":"da Vinci multi-port (X / Xi), da Vinci SP single-port, da Vinci 5 (5th-gen, FDA 510(k) Mar 14 2024, Force Feedback), and Ion endoluminal robotic bronchoscopy (FDA Feb 2019).","height_cm":175.3,"weight_kg":544,"formFactor":"surgical (teleoperated master-slave multi-port + single-port surgical robot; + endoluminal robotic bronchoscopy)","fda_clearance":"da Vinci 5 FDA 510(k) cleared March 14, 2024; Ion FDA cleared February 2019","clearance_body":"FDA"},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://www.sec.gov/Archives/edgar/data/0001035267/000103526726000032/isrg-20260331.htm","title":"Intuitive Form 10-Q (Q1 2026): 11,395 da Vinci installed (1,464 da Vinci 5); 1,041 Ion","sourceName":"SEC EDGAR"},{"url":"https://www.sec.gov/Archives/edgar/data/1035267/000103526726000029/q126ex-991earningsrelease.htm","title":"Intuitive Q1 2026 earnings (procedures +17%; 431 da Vinci placed; revenue $2.77B)","sourceName":"SEC EDGAR"},{"url":"https://www.globenewswire.com/news-release/2024/03/14/2846718/7637/en/Intuitive-Announces-FDA-Clearance-of-Fifth-Generation-Robotic-System-da-Vinci-5.html","title":"Intuitive: FDA clearance of da Vinci 5 (510(k), Mar 14 2024; Force Feedback)","sourceName":"Intuitive (GlobeNewswire)"},{"url":"https://www.therobotreport.com/intuitive-demos-4000-mile-telesurgery-with-da-vinci-5-surgical-robot/","title":"Intuitive demos 4,000-mile telesurgery (investigational, in development)","sourceName":"The Robot Report"},{"url":"https://www.fiercebiotech.com/medtech/intuitive-launches-latest-da-vinci-robot-force-feedback-controls","title":"da Vinci 5 Force Feedback (up to 43% less force, preclinical/marketing figure)","sourceName":"FierceBiotech"},{"url":"https://robotsguide.com/robots/davinci","title":"Da Vinci","sourceName":"Robots Guide"}],"aliases":["da Vinci","da Vinci 5","da Vinci Xi","da Vinci SP","Intuitive Ion"],"collisionRisk":"low","reviewNote":null,"manufacturerTermForTeleop":null,"keyFacts":[{"label":"Installed base","value":"11,395 da Vinci systems as of Q1 2026 (SEC 10-Q, 3/31/2026)"},{"label":"Production target","value":"431 da Vinci placed in Q1 2026 (232 of them da Vinci 5)"},{"label":"Autonomy level","value":"Master-slave teleoperated; shipped analytics AI (Case Insights, machine-vision); Force Feedback is sensing, not autonomy"},{"label":"Form factor","value":"Surgical teleoperated multi-port + single-port; plus endoluminal robotic bronchoscopy"},{"label":"FDA clearance","value":"da Vinci 5 FDA 510(k) cleared March 14, 2024; Ion FDA cleared February 2019"}],"createdAt":"2026-06-03T20:12:00.111Z","updatedAt":"2026-07-22T17:19:25.655Z","unitsInFieldClaimed":null,"unitsInFieldVerified":null,"unitsManufacturedClaimed":null,"unitsManufacturedVerified":null,"unitsAsOf":null,"unitsSource":null,"salesModel":null,"priceUndisclosedSince":null,"autonomyClass":"teleoperated","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":null,"derived":{"status":"active"},"sources":[{"id":"eb57ebb9-d377-4963-b636-4b81296f8613","incidentId":"dca66785-bf0e-47f6-8b40-1ccda41ce097","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=217883","label":"FDA (Class 2 Recall Z-1428-2026)","publishedAt":null,"notes":null,"title":null,"sourceName":null,"mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-22T00:32:22.897Z","updatedAt":"2026-07-22T00:32:22.897Z"}],"responses":[],"statusEvents":[],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/intuitive-davinci5-ui-crash-monitor-loss-recall-2025","url":"https://registry.deploy.report/incidents/intuitive-davinci5-ui-crash-monitor-loss-recall-2025","headline":"Intuitive Surgical recalls 12 da Vinci 5 systems over UI application crash and loss of monitor display","description":"FDA Class 2 recall Z-1428-2026 (firm-initiated Nov 17 2025; posted Feb 18 2026): Software version P1.2.1 caused an increase in Error 48306 events on da Vinci 5 systems in dual console configuration, causing User Interface application crashes and loss of interaction at the affected node. External monitor and tower monitor UI may not display (live endoscopic video still displayed). FDA-determined cause: Software Design Change. 12 units in commerce across 6 US states. Corrective patch P1.2.2 in development.","identifier":"dca66785-bf0e-47f6-8b40-1ccda41ce097","datePublished":"2025-11-17T12:00:00.000Z","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":1,"primary_source_types":["primary-fda-database"]}}}