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Health Canada Medical devices

Monarch Platform

Issued February 19, 2026
Issue
Auris Health, Inc. has identified through internal testing that, in rare cases, a restart of a Monarch software application may occur during procedure setup. If the application restarts after patient-side selection and alignment, but prior to bronchoscope loading, the application will re-initialize the patient-side state to the patient-left position. If the user had previously selected the patient-right position, this re-initialization could result in a mismatch between the system state and the user's intended selection. If unrecognized, this condition could lead to unintended robotic arm movement toward the patient-left position instead of the intended patient-right position during subsequent steps.
Hazard description
Performance
Product
Product name
Monarch Platform
Reference
ID
RA-81627