Recall Z-2194-2008 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems Oncology Systems
Varis Aria Radiation Oncology Version 8.1, manufactured by Varian Medical Systems, Palo Alto, CA The device is designed to assist the operator in providing accurate treatment setups for each patient by monitoring parameters and preventing the device from commencing radiation treatment plan inappropriately.
| Date | Sep 4, 2008 (initiated May 21, 2008) |
| Status | Terminated |
| Reason | Dose delivery may be altered after import from a third party planning system during radiation therapy. |
| Root cause | Software design |
| Action | Recall was initiated on May 21, 2008. A product notification letter (sent via certified mail) was distributed to all affected users, with description of the problem i.e., dose delivery may be altered after import from a third party planning system during radiation therapy . The letter was also distributed to Varian Sites, Marketing and Service Organizations. A software upgrade is currently being developed. For assistance, contact Varian Medical Systems, Oncology Systems at 1-650-424-5731. |
| Quantity | 241 units |
| Distribution | US and to Canada, Australia, Bahrain, Belorussia, Colombia, Finland, Germany, Greece, India, Italy, Japan, Kuwait, Lithuania, Mexico, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, and the UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001643 | VARIS 1.4G Varian Medical Systems, Inc., Jun 23, 2000 |