Recall Z-0014-2012 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta, Inc.
Dynamic Multileaf Collimator (DMLC) Shapes the radiation beam in treatment therapy.
| Date | May 25, 2011 |
| Status | Terminated |
| Reason | It is possible to load different patients in the record and verify (R&V) system and in the multilead control software (MCS). |
| Root cause | Device Design |
| Action | Elekta, Inc. sent an "IMPORTANT NOTICE" letter dated May 25, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter recommends several precautions customers should use until Elekta finds a solution. Customers will be contacted when a solution is found. |
| Quantity | 27 |
| Distribution | Nationwide Distribution-USA including the state of CT, FL, GA, IA, MN, MO, NJ, NY, ND, OH, OK, PA, RI, TX, VA , and 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 |