Recall Z-0910-2011 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems Oncology Systems
C-Series Clinac, Trilogy and Novalis Tx used for SRS treatments, Model Numbers H14, H18, H27, H29, HCX, manufactured by Varian Medical Systems, Palo Alto, CA. Device is a radiation Therapy accelerator intended to deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radi
| Date | Jan 18, 2011 (initiated Oct 8, 2009) |
| Status | Terminated |
| Reason | Product may deliver radiation treatment to areas larger than intended,to healthy tissue. |
| Root cause | Nonconforming Material/Component |
| Action | Varian sent an URGENT MEDICAL DEVICE CORRECTION letter dated October 8, 2009, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Varian recommended to consignees that test runs be performed prior to actual patient treatment to ensure that the entire system is behaving as intended and that appropriate quality assurance procedures should be followed prior tothe delivery of any treatment plan involving radiation therapy. Operators should monitor the patient and the treatment console continuously during treatment. For quest |
| Quantity | 5208 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |