Varian On-Board Imager Device versions 1.2 and 1.3, when used with Cone Beam Computed Tomography. Medical Linear Accelerator.
This recall has been terminated (originally issued August 29, 2007).
- Company
- Varian Medical Systems, Inc.
- Recall Initiated
- April 18, 2007
- Posted
- August 29, 2007
- Terminated
- August 12, 2010
- Recall Number
- Z-1195-2007
- Quantity
- 291 units
- Firm Location
- Palo Alto, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Patient positioning errors may occur because of mechanical variations during product installation.
Distribution
Worldwide, including USA, Puerto Rico, Australia, Belgium, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, India, Ireland, Italy, Japan, Luxembourg, New Zealand, Norway, Poland, Portugal, Spain, Sweden, Switzerland, Netherlands, and United Kingdom.
Lot / Code Info
serial numbers H070002-H072113
Root Cause
Device Design
Action Taken
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.