Varian RV Software Varian Treatment for Non-Varian Linacs Version 6.6.5042 and 6.6.5043; Model Number: H46; Product is m
FDA device recall Z-0164-2009 · posted 2008-10-22 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Oncology Systems
- Reason for recall
- A malfunction within the Varis software might result in a misadministration (underdose). The software does not correctly interpret the number, causing field parameters having decimal values to be incorrect.
- Action taken
- Recall initiated on June 2, 2008. A product notification letter was distributed by certified mail to all affected consignees.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 18
- Distribution
- Worldwide Distribution --- including USA and countries of Canada, Austria, France, Germany, South Korea, Sweden, and the UK.
- Date initiated
- 2008-06-02
- Date posted
- 2008-10-22
- Date terminated
- 2011-05-03
- 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 |