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RobotRisk / Auris Health (J&J MedTech) / 2026-01-21
medical robotics · recall

FDA Class II recall: MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-0

S3 · 01/21
2026 · Auris Health (J&J MedTech)

Record

CompanyAuris Health (J&J MedTech)
Categorymedical robotics
Typerecall
Date01/21
2026
Time of daynot documented
Locationno physical site (recall / fleet-wide / aggregate record)
SeverityS3 (recall, enforcement, or fleet-wide fault)
ScaleMONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-
Confidencehigh
VerificationYes - adversarially checked against the cited source
SourceopenFDA enforcement

What happened

FDA enforcement record (Class II, recall Z-1383-2026): Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application will re-initialize to patient-left position; and if right position was previously selected, this may

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