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Devices
Leksell Gamma Knife C
Model / Serial
4148, 4207, 4214, 4300, 4302, 4303, 4306, 4307, 4308, 4309, 4313, 4314, 4315, 4318, 4319, 4321, 4322, 4326, 4327, 4328, 4329, 4332, 4333, 4334, 4337, 4338, 4339, 4340, 4341, 4342, 4343, 4344, 4346, 4351, 4352, 4353, 4354, 4357, 4363, 4365, 4366, 5000, 5003, 5006, 5009, 5010, 5018, 5019, 5022, 5023, 5026
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
AL, CA, CO, CT, FL, GA, IL, MD, MA, MI, MN, MO, NE, NY, NC, OH, OK, OR, PA, TN, TX, VA, WA
Product Description
Leksell Gamma Knife C
Manufacturer
Elekta, Inc.
1 Event
Recall of Leksell Gamma Knife C
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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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