Recall Z-1195-2007 ยท IYE Accelerator, Linear, Medical
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.
| Date | Aug 29, 2007 (initiated Apr 18, 2007) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |