Recall Z-0978-2014 ยท IXI Block, Beam-Shaping, Radiation Therapy
Elekta, Inc.
DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes of specific shape containing pathology to be treated so that adjacent non-diseased tissues are spared to the extent possible.
| Date | Feb 25, 2014 (initiated May 1, 2013) |
| Status | Terminated |
| Reason | It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems |
| Root cause | Component design/selection |
| Action | Elekta sent an Important Field Safety Notice letter dated May 2013 to affected customers. The letter identified the scope, problem, clinical impact, solution, and safety reference. For question call +44 (0)1293 544422 |
| Quantity | 35 units |
| Distribution | US Nationwide Distribution in the states of CT, FL, GA, IA, MO, NY, ND, OK, RI, TX, VA, WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001163 | DMLC IV-ERGO 3D Line USA, Inc., Oct 23, 2000 |