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Devices
Elekta Synergy XVI R4.5
Model / Serial
Serial Numbers 152019, 152117, 151566, 152271, 151942, 152116, 151141, 151885, 152211, 152214, 152158, 151628, and 152207.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Class 2 Recall -- Nationwide Distribution -- Including CA, MI, MO, ND, OH, OR, RI, VT, and WI.
Product Description
Elekta Synergy XVI R4.5 || Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Manufacturer
Elekta, Inc.
1 Event
Recall of Elekta Synergy XVI R4.5
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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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