Varian Medical Systems, Varis Vision - RT Chart version 7.3.10. For radiation therapy.
FDA device recall Z-1957-2011 · posted 2011-04-12 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- An issue with the Varis Vision software where treatment can occur without the dynamic Multileaf Collimator component and may deliver a higher than expected dose of radiation.
- Action taken
- Varian Medical Systems Urgent Medical Device Correction letters were sent to all affected customers on February 7, 2011.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 421
- Distribution
- Worldwide Distribution.
- Date initiated
- 2011-02-07
- Date posted
- 2011-04-12
- 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 |