CanadaMOSAIQ software from Elekta Solutions AB (versions 3.2.1.0 to 3.2.3.2, VERSION 3.2) is affected. When using Anatomical Position Monitoring during a Comprehensive Motion Management unity treatment, if a baseline shift plan transfer error occurs the baseline shift plan may not load and the original beams may be delivered without the new baseline shift applied. Contact the manufacturer for additional information: application.support.na@elekta.com, +1 855 6935358, https://www.elekta.com.
What's being recalled
Companies: Elekta Solutions AB, Hagaplan 4, Stockholm, Sweden, 11368.
How to identify it
Affected products: MOSAIQ; Lot or serial number: Version 3.2.1.0 to 3.2.3.2; Model or catalogue number: VERSION 3.2
The hazard
When using Anatomical Position Monitoring (APM) during a Comprehensive Motion Management (CMM) unity treatment delivery, if the user performs a baseline shift (BLS) plan and an error occurs during the plan transfer, in some instances, the BLS plan may not load into mosaiq resulting in the original beams being delivered without the new BLS applied.
What to do
Contact the manufacturer if you require additional information.
Email: application.support.na@elekta.com
Tel: +1 855 6935358
https://www.elekta.com
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)
United States