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Devices
Leksell Gamma Knife Perfexion with EXTEND Frame System
Model / Serial
Model #1009633 - Serial Numbers 6004, 6032 and 6078
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution: to the states of MO, VA, and WA.
Product Description
Leksell Gamma Knife Perfexion with EXTEND Frame System, manufactured by Electa Instrument AB, Stockholm, Sweden.
Manufacturer
Elekta, Inc.
1 Event
Recall of Leksell Gamma Knife Perfexion with EXTEND Frame System
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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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