Recall Z-1249-2011 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems Oncology Systems
Varian Radiotherapy delivery system (C-Series Clinac, Trilogy and Novalis Tx), model numbers H14, H17, H18, H23, H26, H29, HCX
| Date | Feb 15, 2011 (initiated Jun 23, 2010) |
| Status | Terminated |
| Reason | Position errors may result in misdelivery of radiation. |
| Root cause | Device Design |
| Action | Varian sent Urgent Medical Device Correction letters on June 23, 2010 by Federal Express to all customers. ***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** Field Safety notification including customer distribution lists, was e-mailed to Varian international Customer Support Managers. Managers will translate to local language if necessary, notify sites by appropriate methods. |
| Quantity | 5741 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |