Official recall record

Monarch Platform

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

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