CanadaLeksell GammaPlan® software (VERSION 11.4) by Elekta Solutions AB is affected. Defining a new stereotactic reference for a frame treatment without first changing an existing obsolete reference to a pre-plan reference may create inconsistent alignment and, if not detected, lead to irradiation of the wrong patient location. Elekta will notify affected customers of safety notice 100-01-102-019 via email, with follow-up contacts as needed.
What's being recalled
Companies: Elekta Solutions AB, Hagaplan 4, Stockholm, Sweden, 11368.
How to identify it
Affected products: Leksell GammaPlan®; Lot or serial number: Not applicable.; Model or catalogue number: VERSION 11.4
The hazard
Defining a new stereotactic reference for a frame treatment without first changing an existing obsolete reference to a pre-plan reference may create inconsistent alignment and, if not detected, lead to irradiation of the wrong patient location.
What to do
Elekta will notify affected customers of safety notice 100-01-102-019 via email, with follow-up contacts as needed.
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