Regulatory Action - Southlake Regional Health Centre

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.

Order to Southlake Regional Health Centre

On June 01, 2010 the Canadian Nuclear Safety Commission (CNSC) issued an order to the Southlake Regional Health Centre in Newmarket, Ontario. The Order required the Southlake Regional Health Centre to submit a complete licence application for the operation of the Elekta Infinity model medical linear accelerator by June 04, 2010. Further, the Order required the Southlake Regional Health Centre to provide to the CNSC evidence to demonstrate that the operation of the Elekta Infinity does not pose a risk to the workers at the Centre or to patients undergoing treatment with the Elekta Infinity accelerators. In addition, the Order required the Southlake Regional Health Centre to assume all liabilities with respect to the use of the Elekta Infinity.

The order will be closed when the above information is submitted and approved by the CNSC and the Elekta Infinity linear accelerator is certified by the CNSC.

Read the order (PDF)