| Class 2 Device Recall Dynamic Multileaf Collimator (DMLC) | |
Date Initiated by Firm | May 25, 2011 |
Create Date | June 26, 2015 |
Recall Status1 |
Terminated 3 on January 14, 2014 |
Recall Number | Z-0014-2012 |
Recall Event ID |
59949 |
510(K)Number | K001163 |
Product Classification |
System, planning, radiation therapy treatment - Product Code MUJ
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Product | Dynamic Multileaf Collimator (DMLC)
Shapes the radiation beam in treatment therapy. |
Code Information |
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 |
Recalling Firm/ Manufacturer |
Elekta, Inc. 4775 Peachtree Industrial Blvd Bldg 300, #300 Norcross GA 30092-3011
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For Additional Information Contact | Thomas Valentine 770-670-2548 |
Manufacturer 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). |
FDA Determined Cause 2 | 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 in Commerce | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = MUJ
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