Recalling Firm / Manufacturer

Varian Medical Systems Inc

Product

Varian On-Board Imager Device versions 1.2 and 1.3, when used with Cone Beam Computed Tomography. Medical Linear Accelerator.

Code Information

serial numbers H070002-H072113

Reason of Recall

Patient positioning errors may occur because of mechanical variations during product installation.

Date Recall Initiated

April 18, 2007

Action

The firm issued a notification letter to all customers April 18, 2007. The firm intends to arrange for service personnel to contact affected sites to verify the calibration of the OBI system, and make arrangements to correct any issues. The firm will also update installation manuals to clearly describe the OBI installation and calibration requirements. Firm Initiated recall is ongoing.

Contact

Source of Information

U.S. FDA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.