Clinac Linear Accelerators; Varian Medical Systems, Palo Alto, CA. Radiation Therapy intended to deliver megavoltage x-r
FDA device recall Z-2893-2011 · posted 2011-07-28 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- The throat cover on the High Energy Clinac may detach if not properly installed and possibly strike a patient.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 278
- Distribution
- Worldwide Distribution-including USA (nationwide)
- Date initiated
- 2011-05-24
- Date posted
- 2011-07-28
- Date terminated
- 2012-03-14
- Location
- Palo Alto, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VARIAN HIGH ENERGY LINEAR ACCELERATOR (K100890) | Varian Medical Systems | 2010-07-13 |