Health product recall

Monarch Platform

Last updated

Summary

Product
Monarch Platform
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Monarch Platform All 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.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Ear, nose and throat
Companies
Auris Health Incorporated
5490 Great America Pkwy, Santa Clara, California, United States, 95054
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-81627

Get notified

Receive emails about new and updated recall and safety alerts.

Subscribe