{"id":"8a92a297-9484-4094-8329-e83a426db800","slug":"brainlab-spine-3d-navigation-software-recall-2019","kind":"recall","headline":"Brainlab recalls spine 3D navigation software for incorrect display","summary":"Brainlab recalled its spine and trauma 3D navigation software after the FDA reported it could incorrectly display patient anatomy during surgery. The company planned to stop distributing the software until an updated version was released.","occurredAt":"2019-07-10T00:00:00.000Z","reviewStatus":"reviewed","modelId":null,"deploymentId":null,"companyId":"74f770b5-9fb3-4d93-8c9c-75d37a1ea305","aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"moderate","rootCauseCategory":null,"rootCauseDetail":null,"affectedUnitsCount":null,"affectedUnitsBasis":null,"remediationStatus":null,"regulatoryAction":null,"regulatoryBody":null,"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":"2026-08-04T16:07:18.125Z","updatedAt":"2026-08-09T05:24:01.599Z","model":null,"deployment":null,"company":{"id":"74f770b5-9fb3-4d93-8c9c-75d37a1ea305","name":"Brainlab","slug":"brainlab","description":"Brainlab is a German digital surgery and radiation therapy company headquartered in Munich, developing robotic-assisted surgery platforms including the [Cirq](/models/cirq) robotic surgical arm and [Loop-X](/models/loop-x) mobile imaging robot. Founded in 1989 by Stefan Vilsmeier, the company's technology is used in over 6,300 hospitals worldwide, with its Robotic Suite (Loop-X, Curve Navigation, and Cirq) cleared by the FDA for spine and cranial procedures. 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The company planned to stop distributing the software until an updated version was released.","identifier":"8a92a297-9484-4094-8329-e83a426db800","datePublished":"2019-07-10T00:00:00.000Z","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"]}}}