Class 2 Device Recall Varian Medical Systems OnBoard Imager, Versions 1.0.15 and 1.2.05

• Date Initiated by Firm: January 03, 2008
• Date Posted: August 15, 2008
• Recall Status: Terminated on November 27, 2010
• Recall Number: Z-1442-2008
• Recall Event ID: 46920
• 510(K)Number: K042720 K041519 K040192
• Product Classification: Medical Linear Accelerator - Product Code IYE
• 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.
• Code Information: All serial numbers between H080002 to H080006, H080008 to H080014, H080016 to H080022, H080024 to H080050, H080052 to H080057, H080059 to H080066, H080068 to H080070, H080072 to H080075, H080077, H080078, H080080 to H080089, H080091, H080092, H080094 to H080105, H080107 to H080117, H080119 to H080134, H080136, H080137, H080139 to H080145, H080147 to H080158, H080160 to H080163, H080166, H080168 to H080200, H080202 to H080222, H080224 to H080228, H080230 to H080232, H080235, H080236, H080239, H080240, H080244, H080246 to H080248, H080251, H080254, H080256 to H080258, H080260 to H080263, H080265 to H080268, H080271 to H080282, H080286 to H080288, H080290 to H080292, H080294, H080296, H080301, H080303, H080304, H080306, H080307, H080309, H080311, H080312, H080314, H080318, H080320, H080321, H080324, H080325, H080328, H080329, H080335, H080348, H080351, H082000 to H082002, H082007, H082009 to H082012, H082020 to H082023, H082026, H082034, H082036, H082038, H082043, H082044, H082048, H082070, H082073, H082088, and H082204 .
• Recalling Firm/ Manufacturer: Varian Medical Systems Oncology Systems; 911 Hansen Way; Palo Alto CA 94304-1028
• For Additional Information Contact: 650-424-5731
• Manufacturer Reason for Recall: If used with a third party radiation therapy treatment planning software system, mistreatment may occur because of a misalignment.
• FDA Determined Cause: Software design
• Action: The firm has upgraded all user sites through normal course of service and installation activities. Notification letters were distributed starting January 03, 2008.
• Quantity in Commerce: 291 units
• Distribution: Worldwide Distribution -- USA including states of GA, MI, NY, MN, TX, TN, CA, MD, KS, AL, KY, CT, WI, LA, NC, NJ, PA, IL, RI, FL, NE, AK, VA, WV, NV, MO, TN, OR, IN, MA, CT, AL, AZ, NH, ID, OH, SC, CO, CT, ND, WA, and UT, and countries of Sweden, Switzerland, Germany, Denmark, Japan, UK, France, Italy, Norway, Taiwan, New Zealand, Canada, Poland, Australia, Colombia, China, Spain, Belgium, Russian Federation, India, Iceland.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IYE and Original Applicant = VARIAN MEDICAL SYSTEMS; 510(K)s with Product Code = IYE and Original Applicant = VARIAN MEDICAL SYSTEMS, INC.