Recall Z-0421-2007 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
Desktop Pro R6.0 & R6.1, Linear Medical Accelerator.
| Date | Feb 7, 2007 (initiated Nov 23, 2006) |
| Status | Terminated |
| Reason | Unexpected Diaphragm movement when manual field size modifications are not saved. |
| Root cause | Software design |
| Action | Consignees were notified by letter on/about 11/23/2006 |
| Quantity | 37 units |
| Distribution | Worldwide distribution ---- including USA states of AZ, AL, CA, CO, FL, GA, IA, MI, NV, OH, OK, PA, WA, WV and Country of Canada . |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982713 | RT DESKTOP Elekta Oncology Systems, Ltd., Nov 2, 1998 |