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RobotRisk / Virtual Incision / 2025-04-23
medical robotics · recall

FDA Class II recall: MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical sur

S3 · 04/23
2025 · Virtual Incision

Record

CompanyVirtual Incision
Categorymedical robotics
Typerecall
Date04/23
2025
Time of daynot documented
Locationno physical site (recall / fleet-wide / aggregate record)
SeverityS3 (recall, enforcement, or fleet-wide fault)
ScaleMIRA SURGICAL SYSTEM, Table mounted miniaturized electromech
Confidencehigh
VerificationYes - adversarially checked against the cited source
SourceopenFDA enforcement

What happened

FDA enforcement record (Class II, recall Z-1905-2025): The MIRA Surgical System Software Version 4.0.3 loaded on the Surgeon Control Console may have the potential to exhibit interrupted motion on the display screen, caused by a software latency between the movement of the hand controllers and the movement of the Surgical Minibot arm

Virtual Incision record context

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medical robotics context

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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

recall: by category

recall: by year

recall: severity profile

Comparable recall events in medical robotics

SevDateCompanyEvent
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
S32025-02-26Intuitive SurgicalClass II recall of da Vinci 5 foot pedal over spring failure
S32024-10-28Noah MedicalFDA Class II recall: Galaxy System (GAL-001).

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