Auris Health (J&J) recalls Monarch robotic bronchoscopy platform over software bug that can flip the virtual scope view
[RECALL]Oct 18, 2023 · Auris Health · Monarch Platform · Surgical robots
Failure Mode
RECALL
Event Date
Oct 18, 2023
Primary Entity
Auris Health
Robotic Platform
Monarch Platform
Jurisdiction / Location
Surgical robots
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
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.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
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
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
Related Incidents & Failure Precedents
6 records on file- Zoox recalls entire 105-vehicle fleet after robotaxi drove into smoke-filled active fire scene[RECALL]
Jul 17, 2026 · Zoox · Zoox Robotaxi · Phoenix
Details - Zoox recalls entire 105-vehicle fleet because robotaxis may not detect heavy smoke and could impede emergency responders[RECALL]
Jul 17, 2026 · Zoox · Zoox Robotaxi · Miami
Details - Zoox recalls 105 robotaxis after vehicle drove into heavy smoke at active Las Vegas fire scene[RECALL]
Jul 17, 2026 · Zoox · Zoox Robotaxi · Miami
Details - Zoox issues software recall after robotaxi drove through heavy smoke at Las Vegas emergency scene[RECALL]
Jul 17, 2026 · Zoox · Zoox Robotaxi · Miami
Details - Zoox recalls 105 robotaxis over failure to detect heavy smoke (NHTSA 26E044)[RECALL]
Jul 17, 2026 · Zoox · Zoox Robotaxi · Miami
Details - Waymo recalls nearly 3,800 robotaxis over freeway construction zone risks[RECALL]
Jun 30, 2026 · Waymo · Waymo Driver (6th gen) · Sacramento, California, USA
Details
Incident Context & FAQ
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.
What robot was involved in Auris Health (J&J) recalls Monarch robotic bronchoscopy platform over software bug that can flip the virtual scope view?
Monarch Platform by Auris Health is the recorded robot involved in this incident.
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.