{"id":"562e1ffd-7f4a-4452-ad4d-e9bbcb5bd31c","slug":"ajrc-citizen-petition-davinci5-power-failure-2026-02","kind":"regulatory_action","headline":"AJRC citizen petition (FDA-2026-P-1299) requests Class I recall of all da Vinci 5 systems over intraoperative power failure defect","summary":"On February 4, 2026, the Amy J. Reed Collaborative for Medical Device Safety (AJRC) filed a citizen petition with the FDA requesting that the Commissioner immediately direct Intuitive Surgical to issue a Class I recall of all model 5 da Vinci Surgical Systems due to a serious intraoperative power failure defect. The petition alleges the defect causes prolonged reboot delay, loss of visualization and control, and potential insufflation loss during surgery. AJRC also requested an urgent medical device safety communication and a warning letter to Intuitive Surgical. The petition was filed via regulations.gov docket FDA-2026-P-1299.","occurredAt":"2026-02-04T00:00:00.000Z","reviewStatus":"reviewed","modelId":"45105ba4-1c1f-4121-9ad4-bb912db1dcfc","deploymentId":"352ff92b-8433-4b12-bbaf-fdb2135058b6","companyId":"e5127536-0ff2-4f0e-8488-64994cb2ffc7","dataCenterId":null,"aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"serious","rootCauseCategory":null,"rootCauseDetail":null,"affectedUnitsCount":null,"affectedUnitsBasis":null,"remediationStatus":null,"regulatoryAction":"inquiry_opened","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":"surgical","latitude":null,"longitude":null,"autonomyClass":null,"legalOutcomeClass":"unknown","createdAt":"2026-07-14T08:44:29.905Z","updatedAt":"2026-07-14T21:53:38.800Z","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 (SEC filing, Mar 2026)","value":"11,395 da Vinci systems as of Mar 31 2026."},{"label":"Q1 2026 placements (company-reported)","value":"431 da Vinci systems placed in Q1 2026, 232 of them da Vinci 5."},{"label":"2025 placements (company-reported)","value":"1,721 systems placed in 2025."},{"label":"Autonomy level","value":"Teleoperated (master-slave), with shipped analytics AI such as Case Insights. Force Feedback is sensing, not autonomy."},{"label":"Form factor","value":"Teleoperated multi-port and single-port surgical systems, plus endoluminal robotic bronchoscopy."},{"label":"FDA clearance","value":"da Vinci 5 received FDA 510(k) clearance on March 14, 2024; Ion was cleared in February 2019."},{"label":"System price (reported)","value":"da Vinci Xi about $1.5M; da Vinci 5 $1.8-2.5M, per Forbes, the ACS Bulletin and analyst estimates."},{"label":"Per-procedure cost (reported)","value":"$700-$3,200 per procedure in disposable instruments and accessories; replacement parts average about $1,900 per operation."},{"label":"EndoWrist instruments","value":"Disposable wristed forceps, scissors, needle drivers, scalpels and electrocautery tools, limited to 10 uses; about $2,300 per 10-use device."},{"label":"Accessory prices (company price list, 2023)","value":"Cannulas $630-683, arm drapes $378-1092 and stapler reloads $2,898."},{"label":"Service contract (reported)","value":"$100K-$175K per system per year."},{"label":"Revenue (FY2025)","value":"$10.06B: instruments and accessories $6.02B (60%), systems $2.47B (24%) and services $1.57B (16%)."},{"label":"Recurring revenue model","value":"Disposables drive the economics: about $1,900 per procedure x 300 procedures a year is about $570K a year per installed system."},{"label":"Gross margin (company-reported)","value":"Non-GAAP gross margin of 69.1% in 2024, guided to 65-66.5% for 2025; GAAP gross profit of $6.64B on $10.06B revenue in 2025."},{"label":"Procedure volume (company-reported, 2025)","value":"3.1M+ da Vinci procedures in 2025 (+18% YoY), 20M+ cumulative, and 300+ per system per year on average."},{"label":"Arms and motors","value":"A patient-side cart with 3-4 arms; 30+ maxon DC motors per system (RE 25, RE 13 with GP 13 gearheads, RE 35) with magnetic encoders."},{"label":"maxon motors (supplier-stated)","value":"Swiss maxon's ironless-rotor, rare-earth-magnet motors give zero cogging; 10,000+ are in daily deployment."},{"label":"Vision system","value":"3D HD endoscope; da Vinci 5 has 4x the pixel resolution of Xi, 785nm Firefly fluorescence imaging and a tip heater for anti-fog."},{"label":"Endoscope and imaging parts (2023 price list)","value":"The endoscope lists at about $25,000; the system also uses camera control units, image synchronizers and high-intensity illuminators."},{"label":"Surgeon console","value":"Dual master manipulators with maxon motors, haptic feedback (Force Feedback on da Vinci 5) and a 3D stereoscopic viewer."},{"label":"da Vinci 5 upgrades (company-stated)","value":"About 150 design innovations and 10,000x the computing power of Xi."},{"label":"Manufacturing","value":"Vertically integrated design, assembly and testing at the Sunnyvale, CA campus (1050 Kifer Rd), with manufacturing and supply chain expanding."}],"createdAt":"2026-06-03T20:12:00.111Z","updatedAt":"2026-10-10T03:48:24.270Z","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":{"id":"352ff92b-8433-4b12-bbaf-fdb2135058b6","modelId":"45105ba4-1c1f-4121-9ad4-bb912db1dcfc","versionId":null,"locationId":"84179297-6783-4778-b888-3c681f25e29b","operatorId":"e5127536-0ff2-4f0e-8488-64994cb2ffc7","ownerId":null,"slug":"da-vinci-5-ku-ansan-korea","status":"operational","firstSeen":"2024-06-01T00:00:00.000Z","statusChangeReason":null,"contractType":null,"pilotOutcome":null,"endedAt":null,"unitsOnSite":1,"tasksPerformed":["surgical_assistance"],"shiftStructure":null,"hoursPerDay":8,"siteType":"hospital","operatorConfirmed":null,"humanSupervisionOnsite":null,"locationPrecisionTier":"verified_coordinates","deploymentScale":"small_2_10","siteEnvironment":"indoor","operatorType":"customer_deployed","sourceQualityTier":3,"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://www.news-medical.net/news/20260708/KU-Ansan-Hospital-introduces-the-Da-Vinci-5-robotic-system-to-boost-surgical-precision.aspx","title":"KU Ansan Hospital introduces the Da Vinci 5 robotic system"}],"notes":"KU Ansan Hospital introduces da Vinci 5 robotic surgical system in South Korea. Features force feedback for tactile force perception.","keyFacts":[{"label":"Hospital","value":"KU Ansan Hospital, South Korea"},{"label":"Feature","value":"Force feedback (tactile perception)"}],"reviewNote":null,"exposureHours":null,"deploymentMilesEstimate":null,"exposureBasis":null,"customerSegment":"healthcare","scaleTier":"pilot_lt10","contractValueUsd":null,"contractValueBasis":null,"customerCompanyId":null,"customerExternalName":null,"createdAt":"2026-08-09T23:52:11.288Z","updatedAt":"2026-08-14T13:33:23.512Z"},"company":{"id":"e5127536-0ff2-4f0e-8488-64994cb2ffc7","name":"Intuitive Surgical","slug":"intuitive-surgical","description":"Dominant surgical-robotics maker (NASDAQ: ISRG; founded 1995, Sunnyvale CA) of the [da Vinci](/models/intuitive-da-vinci) teleoperated surgical robots and the Ion robotic bronchoscopy system; 11,000+ da Vinci installed worldwide.","status":"public","founded":1995,"hq":"Sunnyvale, California, USA","hqLat":37.3688301,"hqLng":-122.036349,"hqGeocodedAt":"2026-08-05T14:34:41.542Z","hqAddress":null,"hqPrecision":null,"website":"https://intuitivesurgical.com","fundingTotal":"231000000","type":"both","roles":["robot_maker","robot_operator"],"reviewStatus":"reviewed","heatIndex":75,"lifecycleState":"active","supersededByCompanyId":null,"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"}],"keyFacts":[{"label":"Installed base","value":"11,395 da Vinci (1,464 da Vinci 5) + 1,041 Ion (SEC 10-Q, Q1 2026)."},{"label":"Gating events","value":"da Vinci 5 FDA-cleared Mar 14 2024; Ion FDA-cleared Feb 2019."},{"label":"Stock listing","value":"NASDAQ: ISRG"},{"label":"Market position","value":"Dominant surgical-robotics maker"},{"label":"da Vinci product type","value":"Teleoperated surgical robot"},{"label":"Ion product type","value":"Robotic bronchoscopy system"},{"label":"Manufacturing","value":"Vertically integrated, manufactures da Vinci Xi, SP, and 5 systems in-house at Sunnyvale campus (surgeon console, patient side cart, instruments). 99%+ uptime."}],"aliases":["Intuitive","ISRG","da Vinci","Intuitive Surgical Inc","da Vinci robot","da Vinci surgical system"],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"factoryLocations":null,"manufacturingCapacity":null,"orgType":null,"burnSignal":null,"litigationEvents":null,"insurancePostureDisclosed":null,"unitEconomicsDisclosed":null,"tickerSymbol":"ISRG","stockExchange":"NASDAQ","secCik":"0001035267","revenueUsd":null,"revenueBasis":null,"revenueAsOf":null,"employeeCount":null,"employeeCountBasis":null,"employeeCountAsOf":null,"marketCapUsd":null,"marketCapAsOf":null,"marketCapSource":null,"createdAt":"2026-06-03T20:11:59.344Z","updatedAt":"2026-10-12T23:41:21.958Z"},"derived":{"status":"active"},"sources":[{"id":"7438d00b-2181-4a3c-a6e9-f6e66ca56b1f","incidentId":"562e1ffd-7f4a-4452-ad4d-e9bbcb5bd31c","url":"https://law.northeastern.edu/ajrc-petitions-fda-for-recall-of-da-vinci-surgical-systems/","label":"Northeastern University School of Law","publishedAt":"2026-02-04T00:00:00.000Z","notes":null,"title":null,"sourceName":"Northeastern University School of Law","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-14T08:44:29.905Z","updatedAt":"2026-07-14T08:44:29.905Z"},{"id":"eeff906e-d1eb-48d0-afc2-0b2ca36c0e1c","incidentId":"562e1ffd-7f4a-4452-ad4d-e9bbcb5bd31c","url":"https://www.regulations.gov/docket/FDA-2026-P-1299","label":"Regulations.gov (FDA docket FDA-2026-P-1299)","publishedAt":null,"notes":null,"title":null,"sourceName":"Regulations.gov (FDA docket FDA-2026-P-1299)","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-14T08:44:29.905Z","updatedAt":"2026-07-14T08:44:29.905Z"}],"responses":[],"statusEvents":[{"id":"4869762d-4a83-4664-b6f8-efa1da83ed1d","incidentId":"562e1ffd-7f4a-4452-ad4d-e9bbcb5bd31c","status":"active","reason":null,"source":"agent:recon","effectiveAt":"2026-07-14T08:44:31.082Z","createdAt":"2026-07-14T08:44:31.082Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/ajrc-citizen-petition-davinci5-power-failure-2026-02","url":"https://registry.deploy.report/incidents/ajrc-citizen-petition-davinci5-power-failure-2026-02","headline":"AJRC citizen petition (FDA-2026-P-1299) requests Class I recall of all da Vinci 5 systems over intraoperative power failure defect","description":"On February 4, 2026, the Amy J. Reed Collaborative for Medical Device Safety (AJRC) filed a citizen petition with the FDA requesting that the Commissioner immediately direct Intuitive Surgical to issue a Class I recall of all model 5 da Vinci Surgical Systems due to a serious intraoperative power failure defect. The petition alleges the defect causes prolonged reboot delay, loss of visualization and control, and potential insufflation loss during surgery. AJRC also requested an urgent medical device safety communication and a warning letter to Intuitive Surgical. The petition was filed via regulations.gov docket FDA-2026-P-1299.","identifier":"562e1ffd-7f4a-4452-ad4d-e9bbcb5bd31c","datePublished":"2026-02-04T00:00:00.000Z","articleSection":"regulatory action","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":2,"primary_source_types":[]}}}