Z-1195-2007

Varian On-Board Imager Device versions 1.2 and 1.3, when used with Cone Beam Computed Tomography. Medical...

Name: Z-1195-2007 Varian On-Board Imager Device versions 1.2 and 1.3, when used with Cone Beam Computed Tomography. Medical...
Creator: Varian Medical Systems Inc
Published: 2007-04-18
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2007-04-18 / Terminated / root cause: design

FDA source

Varian Medical Systems Inc began a recall of Varian On-Board Imager Device versions 1.2 and 1.3, when used with Cone Beam Computed Tomography. Medical Linear Accelerator on 2007-04-18. The reason FDA records is "Patient positioning errors may occur because of mechanical variations during product installation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1195-2007
Status: Terminated
Initiated: 2007-04-18
Posted: 2007-08-29
Terminated: 2010-08-12
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.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Patient positioning errors may occur because of mechanical variations during product installation.
Root cause tag: design
FDA 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 in commerce: 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.
Product codes and lots: serial numbers H070002-H072113

Product code IYE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)