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.

2015

December 16, 2015

Update on regulatory action issued to Elekta Inc.

On December 16, 2015, the CNSC confirmed that Elekta Inc. had complied with all the terms and conditions of the order issued on November 9, 2015. The corrective measures implemented by the company were reviewed and found to be satisfactory by CNSC staff.

November 9, 2015

Order to Elekta, Inc.

On November 9, 2015, the CNSC issued an order to Elekta, Inc., a company based in Atlanta, Georgia, USA. The licensee holds a Class II prescribed equipment independent service provider licence. A licence to service Class II prescribed equipment is required for the installation, upgrade and maintenance of prescribed equipment. Under this licence, Elekta, Inc. is authorized to service such equipment typically installed in radiation therapy clinics throughout Canada.

The order was issued following a notification by the licensee that they had performed unauthorized installation and upgrades of Class II prescribed equipment, rendering it uncertified and therefore contrary to section 10(a) of the Class II Nuclear Facilities and Prescribed Equipment Regulations. The order directed Elekta, Inc. to immediately stop installation of uncertified configurations of medical linear accelerators, stop performing upgrades, apply for certification of their equipment to reflect new upgraded configurations, establish procedures for performing the upgrades in Canada, notify the CNSC of locations where the installations had taken place in Canada and notify the affected Canadian operators.

The prescribed equipment had been operated in a manner that posed no risk to the health and safety of workers, the public or the environment.

The licensee has since complied with all the terms and conditions of the order issued. The corrective measures implemented by the company were reviewed and found to be satisfactory by CNSC staff.

The inspector’s findings also resulted in an administrative monetary penalty (AMP). The CNSC issued the AMP to Elekta, Inc. in the amount of $15,820 because of the licensee’s failure to comply with section 10(a) of the Class II Nuclear Facilities and Prescribed Equipment Regulations and because this is their second violation related to use of uncertified equipment. The previous order (Order 837) was issued to Elekta, Inc. on June 1, 2010. It was the CNSC’s belief that, without strong regulatory action, the violation would recur in the future.

The CNSC confirms that the AMP issued to Elekta, Inc. has been paid and is now considered closed.

2010

June 11, 2010

Update to regulatory action issued on June 1, 2010 to Elekta Inc. and Southlake Regional Health Centre

The CNSC confirms that as of June 9, 2010, Elekta Inc., a manufacturer of medical linear accelerators based in Norcross, Georgia, USA and the Southlake Regional Health Centre in Newmarket, Ontario had complied with all the terms and conditions of the orders issued to them by CNSC inspectors. The orders were issued on June 1, 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 1, 2010, the 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.