CanadaThe Monarch Platform by Auris Health Incorporated (model MON-000006; all lots) is affected. Internal testing found that, in rare cases, a Monarch software application may restart during procedure setup and reinitialize the patient-side state to patient-left, which could produce unintended robotic arm movement toward patient-left instead of the intended patient-right. Contact the manufacturer if you require additional information.
What's being recalled
Companies: Auris Health Incorporated, 5490 Great America Pkwy, Santa Clara, California, United States, 95054.
How to identify it
Affected products: Monarch Platform; Lot or serial number: All lots.; Model or catalogue number: MON-000006
The hazard
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
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)