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RobotRisk / Monteris Medical / 2016-03-25
medical robotics · recall

FDA Class I recall: NeuroBlate System SideFire Select

S4 · 03/25
2016 · Monteris Medical

Record

CompanyMonteris Medical
Categorymedical robotics
Typerecall
Date03/25
2016
Time of daynot documented
Locationno physical site (recall / fleet-wide / aggregate record)
SeverityS4 (serious injury, total loss, or grounding)
ScaleNeuroBlate System SideFire Select
Confidencehigh
VerificationYes - adversarially checked against the cited source
SourceopenFDA enforcement

What happened

FDA enforcement record (Class I, recall Z-1614-2016): Monteris received a report that the sapphire lens on a 2.2SF probe fractured during a LITT procedure, with resulting introduction of C02 into the patient's brain.

Monteris Medical record context

Entries by year and severity

012016 S4: 11162017 S4: 11172019 S3: 1119
S1S2S3S4S5

By incident type

By severity

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2545082015 S2: 12015 S3: 12152016 S3: 32016 S4: 14162017 S4: 11172018 S2: 12018 S3: 12182019 S3: 33192020 S3: 1052020 S5: 3108202021 S3: 1642021 S4: 12021 S5: 3168212022 S2: 12022 S3: 1352022 S5: 10146222023 S3: 2222023 S5: 2224232024 S3: 2692024 S5: 7276242025 S3: 5042025 S5: 4508252026 S1: 12026 S2: 12026 S3: 4262026 S4: 52026 S5: 844126
S1S2S3S4S5

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recall context

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Comparable recall events in medical robotics

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S22026-06-09CMR SurgicalClass II recall of Versius surgeon console over disabled Secure Boot cybersecurity control
S42026-03-25OmnicellFDA Class I recall: Rolls of label stock used with the Omnicell i.v.Station.
S52026-03-11Intuitive SurgicalClass I recall of da Vinci SureForm stapler reloads after patient death
S32026-01-21Auris Health (J&J MedTech)FDA Class II recall: MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-0
S32025-09-12Noah MedicalFDA Class II recall: Brand Name: Galaxy System
S32025-05-23Quantum SurgicalFDA Class II recall: EPIONE Model 30-0001
S32025-04-23Virtual IncisionFDA Class II recall: MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical sur
S32025-02-26Intuitive SurgicalClass II recall of da Vinci 5 foot pedal over spring failure

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