Recall Z-1436-2010 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
iView GT Electronic Portal Imaging Device, used with radiation therapy treatments.
| Date | Apr 26, 2010 (initiated Jul 31, 2009) |
| Status | Terminated |
| Reason | Image problems that have an effect on patient position corrections and on the accuracy of the radiation treatment. |
| Root cause | Software design |
| Action | Elekta sent IMPORTANT NOTICE number A329, dated 31 July, 2009 to all customers. This corresponds with Field Change Order - Documentation 764 00 551 060 "An Important Notice (A329) has been issued for replacement of iViewGT R3.4 Service Pack 2 (SP2) installation CD". Mandatory Field Change Order 764 00 551 059 "Replacement of iViewGT R3.4 installer disk"supersedes FCO 764 00 551 053. |
| Quantity | 121 lots |
| Distribution | Nationwide & Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981790 | IVIEW ELECTRONIC PORTAL IMAGING DEVICE (EPID) MODEL NUMBER IVEW Elekta Oncology Systems, Ltd., Aug 7, 1998 |