Recall Z-2157-2013 ยท IXI Block, Beam-Shaping, Radiation Therapy
Elekta, Inc.
DMLC IV-ERGO - Beam shaping block for Radiation Therapy.
| Date | Sep 4, 2013 (initiated Aug 15, 2013) |
| Status | Terminated |
| Reason | Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are incorrect. |
| Root cause | Device Design |
| Action | Important Field Safety Notices 200 01 406 030 (Changes to your system to improve the safe operation of DMLC) and 200 01 602 031 (Changes to your system to improve the safe operation of 3DLINE DMLC) letters were sent to customers on 8/15/2013 advising them of the issue and recommendations to resolve either by upgrading their system or to discontinue a clinical use of the device. |
| Quantity | 31 |
| Distribution | Nationwide distribution: AL, CT, FL, GA, IA, MS, MO, NJ, NY, ND, OH, OK, PA, RI, TX, VA and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001163 | DMLC IV-ERGO 3D Line USA, Inc., Oct 23, 2000 |