Recall Z-1074-2007 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems Inc
Varian Medical Systems Clinac Medical Linear Accelerator. Clinac 600 C &C/D, Clinac 2100 C, C/D & EX and Clinac 2300 C &C/D
| Date | Jul 12, 2007 (initiated May 2, 2007) |
| Status | Terminated |
| Reason | The wedge tray may slip out of the Clinac interface mount during gantry rotation. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 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, Germany, India, Italy, Japan, New Zealand, Poland, Portugal, Serbia and Montenegro, Singapore, Spain, |
| FDA record | Open on fda.gov |