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Incident · Recall

Auris Health (J&J) recalls Monarch robotic bronchoscopy platform over software bug that can flip the virtual scope view

A software issue in the Auris Health Monarch Platform could produce a flipped image of the virtual bronchoscope view, a navigation and orientation hazard during robotic bronchoscopy. Auris Health is a Johnson & Johnson MedTech company. Source: FDA Class 2 device recall Z-0449-2024 (110 units), accessdata.fda.gov.

Occurred 2023-10-18 · Auris Health · Investigated by FDA

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Track Auris Health (J&J) recalls Monarch robotic bronchoscopy platform over software bug that can flip the virtual scope view

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Sources (1)

  1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?start_search=1&firmlegalnam=Auris&postdatefrom=01/01/2017&postdateto=12/31/2026&PAGENUM=100

Common questions

What happened in Auris Health (J&J) recalls Monarch robotic bronchoscopy platform over software bug that can flip the virtual scope view?
A software issue in the Auris Health Monarch Platform could produce a flipped image of the virtual bronchoscope view, a navigation and orientation hazard during robotic bronchoscopy. Auris Health is a Johnson & Johnson MedTech company. Source: FDA Class 2 device recall Z-0449-2024 (110 units), accessdata.fda.gov.
When did this incident occur?
The incident is recorded as occurring on October 18, 2023 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
Who was involved in Auris Health (J&J) recalls Monarch robotic bronchoscopy platform over software bug that can flip the virtual scope view?
The incident is recorded as involving Auris Health on the DEPLOY registry. No specific robot model is linked to this incident in the registry.
Has anyone responded to Auris Health (J&J) recalls Monarch robotic bronchoscopy platform over software bug that can flip the virtual scope view?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of Auris Health (J&J) recalls Monarch robotic bronchoscopy platform over software bug that can flip the virtual scope view?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 1 source (1 primary) · last reviewed 2026-08-09

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-08-09

Sources by quality tier

1
primary-fda-database
FDA database

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for Auris Health (J&J) recalls Monarch robotic bronchoscopy platform over software bug that can flip the virtual scope view.

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Canonical ID d5945e85-7507-41dd-851c-8ca2084b57f9