{"id":"622ce5ab-b136-479d-8631-33ec3aa0491e","slug":"recall-2024-08-05-quantum-surgical","kind":"recall","headline":"FDA Class 2 recall of Epione needle guide component due to rust","summary":"Quantum Surgical issued an urgent field safety notice for 2 Epione units in Florida after discovering rust on a component (central axis) inside the Needle Guide product (product number 02-0027). The affected units were returned, repaired, and replaced. Recall was completed by October 2024.","occurredAt":"2024-08-05T12:00:00.000Z","reviewStatus":"unreviewed","modelId":"ba28973f-6a33-4cce-a22f-d34a99443937","deploymentId":null,"companyId":"cb6a0ecc-6b4d-486d-9356-ea9c928ba0ed","aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"moderate","rootCauseCategory":null,"rootCauseDetail":null,"affectedUnitsCount":null,"affectedUnitsBasis":null,"remediationStatus":null,"regulatoryAction":"recall_ordered","regulatoryBody":"FDA","propertyDamageEstimateUsd":null,"damageEstimateBasis":null,"bodilyInjurySeverity":null,"fatalityCount":null,"lossCostClass":null,"sourceQualityTier":null,"createdAt":"2026-07-06T15:07:24.028Z","updatedAt":"2026-07-06T15:07:24.028Z","model":{"id":"ba28973f-6a33-4cce-a22f-d34a99443937","companyId":"cb6a0ecc-6b4d-486d-9356-ea9c928ba0ed","modelName":"Epione","slug":"epione","description":"","formFactor":"surgical","maturityStage":"commercial","lifecycleState":"active","supersededByModelId":null,"specs":{},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://www.quantumsurgical.com/news/fda-clears-quantum-surgicals-epione-robot-for-all-abdominal-cancers","title":"FDA clears Quantum Surgical's Epione robot for all abdominal cancers","sourceName":"Quantum Surgical"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"manufacturerTermForTeleop":null,"keyFacts":[],"createdAt":"2026-07-06T14:11:34.647Z","updatedAt":"2026-07-06T15:24:11.085Z"},"deployment":null,"company":{"id":"cb6a0ecc-6b4d-486d-9356-ea9c928ba0ed","name":"Quantum Surgical","slug":"quantum-surgical","description":"French medical robotics company developing the [Epione](/models/epione) robotic platform for CT-guided percutaneous tumor ablation, enabling minimally invasive treatment of abdominal, lung, and bone cancers. Founded in 2017 by a team of former [Medtech SA](/companies/medtech-sa) engineers led by Bertin Nahum, the company is headquartered in Montpellier with a US subsidiary in Miami. Now part of Precision IO Group after acquiring NeuWave Medical in February 2026, with over 1,400 patients treated across Europe and the United States.","status":null,"founded":2017,"hq":"Montpellier, France","fundingTotal":"86923000","type":"hardware","reviewStatus":"reviewed","sources":[{"url":"https://www.quantumsurgical.com/news/fda-clears-quantum-surgicals-epione-robot-for-all-abdominal-cancers","title":"FDA clears Quantum Surgical's Epione robot for all abdominal cancers","sourceName":"Quantum Surgical"}],"keyFacts":[{"label":"FDA cleared","value":"abdominal ablation indication"},{"label":"CE marked","value":"abdomen, chest, musculoskeletal"},{"label":"Acquired NeuWave Medical","value":"Feb 2026"},{"label":"CEO","value":"Bertin Nahum (President & Co-founder)"},{"label":"Group CEO","value":"Kurt Azarbarzin (Precision IO Group, appointed Feb 2026)"},{"label":"Co-founders","value":"Bertin Nahum, Fernand Badano, Lucien Blondel, Sophie Roca"},{"label":"Total funding","value":"approx 90M USD (50M EUR equity + 30M EUR EIB loan)"},{"label":"FDA clearance","value":"510(k) K223758 for abdominal tumor ablation"},{"label":"CE mark","value":"abdomen, lung, and musculoskeletal indications"},{"label":"Parent company","value":"Precision IO Group Inc. (since Feb 2026)"},{"label":"Patients treated","value":"1400+ (as of 2026)"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"createdAt":"2026-07-06T14:11:34.262Z","updatedAt":"2026-07-06T15:24:10.692Z"},"derived":{"status":"active"},"sources":[{"id":"5e14fc01-91e4-4ea6-a56e-b63003e6b6b3","incidentId":"622ce5ab-b136-479d-8631-33ec3aa0491e","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=209707","label":null,"publishedAt":null,"notes":null,"title":"Class 2 Device Recall QUANTUM Surgical EPIONE","sourceName":"FDA Recall Database","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-06T15:07:24.416Z","updatedAt":"2026-07-06T15:07:24.416Z"}],"responses":[],"statusEvents":[{"id":"695baae6-77ae-4976-9c73-cd71c10d2103","incidentId":"622ce5ab-b136-479d-8631-33ec3aa0491e","status":"active","reason":null,"source":"agent:depth","effectiveAt":"2026-07-06T15:07:24.796Z","createdAt":"2026-07-06T15:07:24.798Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/recall-2024-08-05-quantum-surgical","url":"https://registry.deploy.report/incidents/recall-2024-08-05-quantum-surgical","headline":"FDA Class 2 recall of Epione needle guide component due to rust","description":"Quantum Surgical issued an urgent field safety notice for 2 Epione units in Florida after discovering rust on a component (central axis) inside the Needle Guide product (product number 02-0027). The affected units were returned, repaired, and replaced. Recall was completed by October 2024.","identifier":"622ce5ab-b136-479d-8631-33ec3aa0491e","datePublished":"2024-08-05T12:00:00.000Z","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"]}}}