Recall Z-1375-06 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems Oncology Systems
Varis Vision Treatment 6.6/RTP Exchange/Siemens Accelerators
| Date | Aug 5, 2006 (initiated Sep 20, 2005) |
| Status | Terminated |
| 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 . |
| Root cause | Software design |
| 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. |
| Quantity | 58 units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050479 | 4D INTEGRATED TREATMENT CONSOLE Varian Medical Systems, Mar 24, 2005 |