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.
FDA Recall Z-1442-2008 · Posted 2008-08-15
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Recalling FirmVarian Medical Systems Oncology Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2008-01-03
Date Terminated2010-11-27
Product Quantity291 units
Reason for Recall
If used with a third party radiation therapy treatment planning software system, mistreatment may occur because of a misalignment.
Firm Action
The firm has upgraded all user sites through normal course of service and installation activities. Notification letters were distributed starting January 03, 2008.
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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