Answer

What incidents have involved Monarch Platform?

Q: What incidents have involved Monarch Platform?

As of 2026-08-25, the DEPLOY registry records 7 tracked incident(s) involving Monarch Platform. Severity distribution: 0 catastrophic, 0 critical, 6 serious, 1 moderate, 0 minor.

Every tracked incident involving Monarch Platform from Auris Health. As of 2026-08-25, 7 tracked incidents on record.

6 serious1 moderate

Every incident, most recent first

Auris Monarch bronchoscope: Navigation EM error at the docking station, scope removed (FDA MAUDE)
moderatemalfunctionFDA (MAUDE)none
2026-05-08
Auris Monarch: patient developed pneumothorax post-procedure requiring chest-tube placement (FDA MAUDE)
seriousinjuryFDA (MAUDE)none
2026-04-30
Auris Health (J&J) recalls Monarch over unanticipated robotic arm positioning toward patient-left
seriousrecallFDArecall ordered
2026-01-21
Auris Health (J&J) recalls Monarch bronchoscopes over out-of-range leak-test results
seriousrecallFDArecall ordered
2025-10-18
Auris Health (J&J) recalls Monarch over a power-cord strain-relief electrical short
seriousrecallFDArecall ordered
2024-08-02
Auris Health (J&J) recalls Monarch robotic bronchoscopy platform over software bug that can flip the virtual scope view
seriousrecallFDArecall ordered
2023-10-18
Auris Health (J&J) recalls Monarch Aspirating Biopsy Needle over reports of needle breakage
seriousrecallFDArecall ordered
2019-04-19

Rebuilt every 15 minutes. Filter: incidents.model_id = Monarch Platform. Severity ladder: catastrophic, critical, serious, moderate, minor. Kind is orthogonal to severity (collision, recall, malfunction, injury, fatality, and others). This page renders only for models with 3 or more tracked incidents; thinner records 404 rather than surface a one-off. See the full Monarch Platform record for specs, deployments, and supply chain.