Regulatory Action - Elekta Inc.
Under the Nuclear Safety and Control Act and associated regulations, various levels of regulatory action can be taken by the Canadian Nuclear Safety Commission (CNSC) to protect the health, safety and security of Canadians and the environment.
2010
June 11, 2010
Update to regulatory action issued on June 1, 2010 to Elekta Inc. and Southlake Regional Health Centre
The Canadian Nuclear Safety Commission (CNSC) confirms that as of June 09, 2010, Elekta Inc., a manufacturer of medical linear accelerators based in Norcross, Georgia, USA, and the Southlake Regional Health Centre in Newmarket, Ontario, have complied with all the terms and conditions of the orders issued to them by CNSC inspectors. The orders were issued on June 01, 2010, in relation to the Elekta Infinity brand linear accelerator, which had not been certified by the CNSC.
The CNSC has issued a Class II Prescribed Equipment Certificate for the Elekta Infinity accelerator, and amended the licence issued to Elekta Inc. to permit servicing on the newly-certified accelerator. The CNSC has also amended the licences issued to the Southlake Regional Health Centre, to authorize the operation and servicing of the newly certified Elekta Infinity accelerator at this facility.
June 1, 2010
Order to Elekta Inc.
On June 01, 2010, the Canadian Nuclear Safety Commission (CNSC) issued an order to Elekta Inc., a manufacturer of medical linear accelerators based in Norcross, Georgia, USA. The order requires that Elekta immediately suspend sales and services in Canada, of the Elekta Infinity brand linear accelerator and submit to the CNSC by June 2, 2010, an application for the certification of the Elekta Infinity model accelerator. Further, the order requires that Elekta limit its servicing activities related the Elekta Infinity linear accelerator to those interventions that, if not carried out, could compromise the health and safety of patients or operators.
Read the order (PDF)
