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RobotRisk / Noah Medical / 2025-09-12
medical robotics · recall

FDA Class II recall: Brand Name: Galaxy System

S3 · 09/12
2025 · Noah Medical

Record

CompanyNoah Medical
Categorymedical robotics
Typerecall
Date09/12
2025
Time of daynot documented
Locationno physical site (recall / fleet-wide / aggregate record)
SeverityS3 (recall, enforcement, or fleet-wide fault)
ScaleBrand Name: Galaxy System
Confidencehigh
VerificationYes - adversarially checked against the cited source
SourceopenFDA enforcement

What happened

FDA enforcement record (Class II, recall Z-0598-2026): Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.

Noah Medical record context

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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
S32025-05-23Quantum 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
S32024-10-28Noah MedicalFDA Class II recall: Galaxy System (GAL-001).

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