Recall Z-2893-2011 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
Clinac Linear Accelerators; Varian Medical Systems, Palo Alto, CA. Radiation Therapy intended to deliver megavoltage x-ray treatments for conventional radiotherapy and stereotactic radiosurgery and radiotherapy.
| Date | Jul 28, 2011 (initiated May 24, 2011) |
| Status | Terminated |
| Reason | The throat cover on the High Energy Clinac may detach if not properly installed and possibly strike a patient. |
| Root cause | Device Design |
| Action | Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated May 24, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter provides directions on how to re-install the gantry center throat cover. Customers can contact their Varian Customer Support Manager at 1-888-827-4265 for further clarification. |
| Quantity | 278 |
| Distribution | Worldwide Distribution-including USA (nationwide) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100890 | VARIAN HIGH ENERGY LINEAR ACCELERATOR Varian Medical Systems, Jul 13, 2010 |