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Devices
Device Recall Dynamic Multileaf Collimator (DMLC)
Model / Serial
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
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
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.
Product Description
Dynamic Multileaf Collimator (DMLC) || Shapes the radiation beam in treatment therapy.
Manufacturer
Elekta, Inc.
1 Event
Recall of Device Recall Dynamic Multileaf Collimator (DMLC)
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Manufacturer
Elekta, Inc.
Manufacturer Address
Elekta, Inc., 4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross GA 30092-3011
Manufacturer Parent Company (2017)
Elekta AB
Source
USFDA
Language
English
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