Varian Medical Systems Clinac Medical Linear Accelerator. Clinac 600 C &C/D, Clinac 2100 C, C/D & EX and Clinac 2300 C &
FDA device recall Z-1074-2007 · posted 2007-07-12 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Inc
- Reason for recall
- The wedge tray may slip out of the Clinac interface mount during gantry rotation.
- Action taken
- The firm sent out a Product Notification Letter on 5/2/07 to customers who have ordered this guide block through a Varian Service Center. A Varian Field Engineer will visually inspect guide blocks at-site that have been installed from Service stock for all affected customers, and replace if necessary.
- Root cause
- Process control
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 209 units
- Distribution
- Product was distributed and manufactured between 1999 and 2006. Distributed worldwide, including USA, Ecuador, Columbia, Taiwan, Austrailia, Austria, Brazil, Canada, Chile, China, Finland, France, Ger
- Date initiated
- 2007-05-02
- Date posted
- 2007-07-12
- 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 |
|---|---|---|
| VARIAN C-SERIES CLINACS (CLINAC 2300C/D) (K913119) | Varian Assoc., Inc. | 1991-11-07 |
| CLINAC (R) C SERIES (400C, 600C, 2100C, 2500C) (K862645) | Varian Assoc., Inc. | 1986-10-03 |