Dynamic Multileaf Collimator (DMLC) Shapes the radiation beam in treatment therapy.
This recall has been terminated (originally issued May 25, 2011).
- Company
- Elekta, Inc.
- Recall Initiated
- May 25, 2011
- Terminated
- January 14, 2014
- Recall Number
- Z-0014-2012
- Quantity
- 27
- Firm Location
- Norcross, GA
- Official Source
- View on FDA website ↗
Reason for Recall
It is possible to load different patients in the record and verify (R&V) system and in the multilead control software (MCS).
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.
Lot / Code Info
116001, 116012, 116044, EM7-008, 116055, 116064, 116014, 116052, 116023, 116056, 116053, 116047, 116043, 116051, 116070, 116122, 116063, 116020, EM7-003, EM-029, EM7-006, 116024, 116068, 116013, EM3-026, EM3-004, 116046
Root Cause
Device Design
Action Taken
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.