Varis Aria Radiation Oncology Version 8.1, manufactured by Varian Medical Systems, Palo Alto, CA The device is designed
FDA device recall Z-2194-2008 · posted 2008-09-04 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Oncology Systems
- Reason for recall
- Dose delivery may be altered after import from a third party planning system during radiation therapy.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 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 th
- Date initiated
- 2008-05-21
- Date posted
- 2008-09-04
- Date terminated
- 2010-11-27
- 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 |
|---|---|---|
| VARIS 1.4G (K001643) | Varian Medical Systems, Inc. | 2000-06-23 |