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Devices
Device Recall Leksell Gamma Knife.
Model / Serial
LGK 4203, LGK 4309, LGK 4333, LGK 4343 and LGK 4354.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
United States (CA, TN, TX and WA) and Taiwan.
Product Description
Leksell Gamma Knife. || Leksell Gamma Knife is a teletherapy device indicated for use in the stereotactic irradiation of intracranial structures
Manufacturer
Elekta, Inc.
1 Event
Recall of Device Recall Leksell Gamma Knife.
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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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