{"id":"d09c1728-a510-4116-86b0-fe0f3a9dd642","slug":"cmr-surgical-versius-secure-boot-recall-2026-06","kind":"recall","headline":"CMR Surgical recalls Versius Surgical System consoles due to Secure Boot cybersecurity vulnerability","summary":"CMR Surgical initiated a Class 2 recall (Z-2717-2026) of two Versius Surgeon Console units (Model V-SS-1020) because Secure Boot was mistakenly not enabled at manufacturing time, presenting a potential cybersecurity risk. The affected units were distributed in California; the firm began notifying customers on June 16, 2026, and will proactively configure Secure Boot on the affected consoles.","occurredAt":"2026-06-09T00:00:00.000Z","reviewStatus":"unreviewed","modelId":null,"deploymentId":null,"companyId":"6bbb447e-0278-4ae1-822d-8b546420511e","dataCenterId":null,"aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"moderate","rootCauseCategory":null,"rootCauseDetail":null,"affectedUnitsCount":2,"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":null,"longitude":null,"autonomyClass":null,"legalOutcomeClass":"unknown","createdAt":"2026-08-17T14:04:15.727Z","updatedAt":"2026-08-17T14:04:15.727Z","model":null,"deployment":null,"company":{"id":"6bbb447e-0278-4ae1-822d-8b546420511e","name":"CMR Surgical","slug":"cmr-surgical","description":"UK surgical-robotics company (Cambridge; founded 2014) making the Versius modular multi-arm teleoperated surgical robot; FDA De Novo 2024 + Versius Plus 510(k) 2025; >40k procedures ex-US.","status":"private (recapitalized $200M+ Apr 2025; current valuation unconfirmed)","founded":2014,"hq":"Cambridge, United Kingdom","hqLat":52.1975846,"hqLng":0.1391537,"hqGeocodedAt":"2026-08-05T00:50:46.343Z","hqAddress":null,"hqPrecision":null,"website":"cmrsurgical.com","fundingTotal":null,"type":"both","reviewStatus":"reviewed","lifecycleState":"active","supersededByCompanyId":null,"sources":[{"url":"https://www.globenewswire.com/news-release/2024/10/15/cmr-surgical-versius-fda-de-novo","title":"CMR Surgical receives US FDA De Novo for Versius (cholecystectomy; Oct 2024)","sourceName":"CMR Surgical (GlobeNewswire)"},{"url":"https://www.therobotreport.com/cmr-surgical-receives-fda-clearance-for-versius-plus-surgical-robot/","title":"CMR Surgical FDA 510(k) for Versius Plus (Dec 18 2025; US launch 2026)","sourceName":"The Robot Report"},{"url":"https://www.massdevice.com/cmr-surgical-200-million-funding/","title":"CMR Surgical raises $200M+ to fund US/Asia commercialization (Apr 2025)","sourceName":"MassDevice"},{"url":"https://www.globenewswire.com/news-release/2026/03/17/cmr-surgical-nvidia-igx-thor","title":"CMR Surgical + NVIDIA IGX Thor (evaluating AI for next-gen Versius; R&D-stage)","sourceName":"CMR Surgical (GlobeNewswire)"}],"keyFacts":[{"label":"Product","value":"Versius / Versius Plus modular multi-arm teleoperated surgical robot."},{"label":"Gating events","value":"FDA De Novo Oct 2024; Versius Plus 510(k) Dec 2025; gynecology 510(k) pending."},{"label":"wikidata","value":"https://www.wikidata.org/wiki/Q60775579"},{"label":"wikipedia","value":"https://en.wikipedia.org/wiki/CMR_Surgical"},{"label":"Founded","value":"2014, Cambridge, UK"},{"label":"Key product","value":"Versius surgical robot system"},{"label":"FDA clearance","value":"Versius Plus secured"}],"aliases":["CMR","Cambridge Medical Robotics","Versius"],"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":"2026-06-03T20:12:28.328Z","updatedAt":"2026-08-05T02:17:05.420Z"},"derived":{"status":"active"},"sources":[{"id":"f69cc0b3-b54c-4dd1-9aea-23cda6036fa5","incidentId":"d09c1728-a510-4116-86b0-fe0f3a9dd642","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99280","label":"FDA","publishedAt":"2026-07-09T00:00:00.000Z","notes":null,"title":null,"sourceName":"FDA","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-08-17T14:04:15.727Z","updatedAt":"2026-08-17T14:04:15.727Z"}],"responses":[],"statusEvents":[{"id":"d03868c0-ce8e-4af9-941f-e52da5219aa1","incidentId":"d09c1728-a510-4116-86b0-fe0f3a9dd642","status":"active","reason":null,"source":"agent:recon","effectiveAt":"2026-08-17T14:04:16.887Z","createdAt":"2026-08-17T14:04:16.887Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/cmr-surgical-versius-secure-boot-recall-2026-06","url":"https://registry.deploy.report/incidents/cmr-surgical-versius-secure-boot-recall-2026-06","headline":"CMR Surgical recalls Versius Surgical System consoles due to Secure Boot cybersecurity vulnerability","description":"CMR Surgical initiated a Class 2 recall (Z-2717-2026) of two Versius Surgeon Console units (Model V-SS-1020) because Secure Boot was mistakenly not enabled at manufacturing time, presenting a potential cybersecurity risk. The affected units were distributed in California; the firm began notifying customers on June 16, 2026, and will proactively configure Secure Boot on the affected consoles.","identifier":"d09c1728-a510-4116-86b0-fe0f3a9dd642","datePublished":"2026-06-09T00:00:00.000Z","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"]}}}