Varis Vision Treatment 6.6/RTP Exchange/Siemens Accelerators
FDA device recall Z-1375-06 · posted 2006-08-05 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Oncology Systems
- Reason for recall
- 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 taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 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 t
- Date initiated
- 2005-09-20
- Date posted
- 2006-08-05
- Date terminated
- 2006-11-21
- Location
- Palo Alto, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 4D INTEGRATED TREATMENT CONSOLE (K050479) | Varian Medical Systems | 2005-03-24 |