FDA Recall
Terminated
Varis Vision Treatment 6.6/RTP Exchange/Siemens Accelerators
Recall: Z-1375-06
·
Initiated September 20, 2005
Recall
- Recall Number
- Z-1375-06
- Event Number
- 35886
- Firm
- Varian Medical Systems Oncology Systems
- FEI Number
- 2916710
- Product Code
- IYE
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- September 20, 2005
- Posted
- August 5, 2006
- Terminated
- November 21, 2006
- Address
- 911 Hansen Way, Palo Alto, CA, 94304-1028
Description
Varis Vision Treatment 6.6/RTP Exchange/Siemens Accelerators
Reason
A software anomaly may occur which can lead to patient treatment with the wrong field. The anomaly is reported only to occur when this software version (6.6.5022) is used with Elekta or Siemens linear accelerators .
Action
On 09/20/2005, Varian Medical Systems issued a notification letter via certified mail and FedEx. These letters were issued with instructions on what to do regarding the corrections. Varian Medical Systems intends to release new, updated software.
Distribution
The product was distributed to 34 consignees, located in AZ, CA, MA, MI, NC, PA in the USA, and in Australia, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Lithuania, Spain, Sweden, and the United Kingdom
Quantity
58 units