Varis, Aria Radiation Oncology - Version 8.1.15, 8.5.11, and 8.6.07, Model number HIT-INFSYS, Manufactured by Varian Med
FDA device recall Z-1809-2009 · posted 2009-08-27 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Oncology Systems
- Reason for recall
- Potential mistreatment-- due to software issues, retired plans may be used and treated repeatedly.
- Action taken
- An Urgent Medical Device Correction Letter/ Field Safety Letter, dated May 8, 2009, were distributed to all affected users, with a description of the problem and user corrective action steps. The Letter will also be distributed to the Varian Sales, Marketing, and Service organizations, informing them of the issue. The firm intends to produce a software fix for the problem. If further clarification is needed, users should contact their Varian Customer Support District or Regional Manager.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 1,587 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2009-05-08
- Date posted
- 2009-08-27
- Date terminated
- 2011-12-23
- 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 |