Health Products

Monarch Platform

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Ear, nose and throat
Product: Monarch Platform
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Monarch PlatformAll lots.MON-000006

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.

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