Varian Medical Systems Inc Varian On-Board Imager Device versions 1.2 and 1.3, when used with Cone Beam Computed Tomography. Medical Linear Accelerator. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Varian On-Board Imager Device versions 1.2 and 1.3, when used with Cone Beam Computed Tomography. Medical Linear Accelerator.
Brand
Varian Medical Systems Inc
Lot Codes / Batch Numbers
serial numbers H070002-H072113
Products Sold
serial numbers H070002-H072113
Varian Medical Systems Inc is recalling Varian On-Board Imager Device versions 1.2 and 1.3, when used with Cone Beam Computed Tomography. M due to Patient positioning errors may occur because of mechanical variations during product installation.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Patient positioning errors may occur because of mechanical variations during product installation.
Recommended Action
Per FDA guidance
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.
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
PR
Page updated: Jan 10, 2026