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Devices
Infinia with Hawkeye 1
Model / Serial
All serial numbers associated with model numbers H2508PW, H2508PY, H3000WN, H3000WR, H3000WW, H3000WY, H3000WZ, H3000YM, and H3000YS.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
Infinia with Hawkeye 1, model numbers: H2508PW, H2508PY, H3000WN, H3000WR, H3000WW, H3000WY, H3000WZ, H3000YM, and H3000YS. GE Healthcare, Waukesha, Wisconsin 53118. || Generating head and whole body CT images of human subjects
Manufacturer
GE Medical Systems, LLC
1 Event
Recall of Infinia with Hawkeye 1
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Manufacturer
GE Medical Systems, LLC
Manufacturer Address
GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
Manufacturer Parent Company (2017)
General Electric Company
Source
USFDA
Language
English
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