{"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":null,"deploymentId":null,"companyId":"e5127536-0ff2-4f0e-8488-64994cb2ffc7","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,"createdAt":"2026-07-14T08:44:29.905Z","updatedAt":"2026-07-14T21:53:38.800Z","model":null,"deployment":null,"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 (NASDAQ: ISRG)","founded":1995,"hq":"Sunnyvale, California, USA","fundingTotal":null,"type":"both","reviewStatus":"reviewed","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":"Hero image candidate","value":"https://upload.wikimedia.org/wikipedia/commons/7/77/New_Da_Vinci_Xi.jpg (source: Wikimedia Commons, license: CC BY-SA 4.0)"}],"aliases":["Intuitive","ISRG","da Vinci"],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"factoryLocations":null,"manufacturingCapacity":null,"orgType":null,"burnSignal":null,"litigationEvents":null,"insurancePostureDisclosed":null,"unitEconomicsDisclosed":null,"createdAt":"2026-06-03T20:11:59.344Z","updatedAt":"2026-07-07T21:55:07.582Z"},"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":[]}}}