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Devices
Elekta DMLC
Model / Serial
EM-042, EM7-004, EM-046, EM-060, EM-047, EM-029, EM7-003, EM7-002, EM7-008, EM-062, EM-063, EM3-004, 116001, 116012, 116044, 116055, 116014, 116052, 116023, 116056, 116053, 116043, 116047, 116051, 116122, 116068, 116013, 116046
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide distribution: AL, CT, FL, GA, IA, MS, MO, NJ, NY, ND, OH, OK, PA, RI, TX, VA and Puerto Rico.
Product Description
DMLC IV-ERGO - Beam shaping block for Radiation Therapy.
Manufacturer
Elekta, Inc.
1 Event
Recall of Elekta DMLC
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Manufacturer
Elekta, Inc.
Manufacturer Address
Elekta, Inc., 400 Perimeter Center Ter Ne, Ste 50, Atlanta GA 30346-1227
Manufacturer Parent Company (2017)
Elekta AB
Source
USFDA
Language
English
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