Cl Il Varian Medical Systems On-Board Imager

Company: Varian Medical Systems Oncology Systems
Date of Enforcement Report 8/20/2008
Class:ll

PRODUCT
Varian Medical Systems On-Board Imager, Versions 1.0.15 and 1.2.05 Imaging Accessory to Medical Linear Accelerator. The On-Board Imager Device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial landmarks, Recall # Z-1442-2008

REASON
If used with a third party radiation therapy treatment planning software system, mistreatment may occur because of a misalignment.

RECALLING FIRM/MANUFACTURER
Varian Medical Systems Oncology Systems, Palo Alto, CA, by letters starting January 3, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
291 units

DISTRIBUTION
Nationwide and Internationally

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.