Varian Medical Systems Oncology Systems 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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Varian Medical Systems Oncology Systems
Lot Codes / Batch Numbers
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 .
Products Sold
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 .
Varian Medical Systems Oncology Systems is recalling Varian Medical Systems On-Board Imager, Versions 1.0.15 and 1.2.05 Imaging Accessory to Medical Line due to If used with a third party radiation therapy treatment planning software system, mistreatment may occur because of a misalignment.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
If used with a third party radiation therapy treatment planning software system, mistreatment may occur because of a misalignment.
Recommended Action
Per FDA guidance
The firm has upgraded all user sites through normal course of service and installation activities. Notification letters were distributed starting January 03, 2008.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MN, MO, NE, NV, NH, NJ, NY, NC, ND, OH, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, WI
Page updated: Jan 10, 2026