Exact Couch with Exact Couch Top, a component of the C-Series Clinacs, Acuity and Ximatron treatment systems. Model numb
FDA device recall Z-0117-2009 · posted 2008-10-20 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Oncology Systems
- Reason for recall
- During couch movement, a patient's fingers may get pinched at certain points which could result in broken, disengaged or pinched fingers.
- Action taken
- Recall initiated on 08/11/2008. Notification will be sent to Varian Sales, Marketing and Service organizations as well as to all affected users. Contact Varian Medical Systems Oncology Systems, at 1-650-424-5731 for assistance.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 3296 units
- Distribution
- Worldwide including to the US and to Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portu
- Date initiated
- 2008-08-11
- Date posted
- 2008-10-20
- 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 |
|---|---|---|
| ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY (K033339) | Varian Medical Systems, Inc. | 2003-12-30 |
| VARIAN C-SERIES CLINACS CLINAC 600C,2100C,2500C (K904364) | Varian Assoc., Inc. | 1991-02-27 |