FDA Medical Device Recalls (openFDA)
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 number
- Z-1195-2007
- Recalling firm
- Varian Medical Systems Inc
- Product
- Varian On-Board Imager Device versions 1.2 and 1.3, when used with Cone Beam Computed Tomography. Medical Linear Accelerator.
- Status
- Terminated
- Initiated
- 2007-04-18
- Posted
- 2007-08-29
- Terminated
- 2010-08-12
- Reason
- Patient positioning errors may occur because of mechanical variations during product installation.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 291 units
- 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, serial or model codes
- serial numbers H070002-H072113
- 510(k) numbers
- ["K040192","K041519","K042720"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 2916710
- Firm city
- Palo Alto
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28