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Device Recall BrightSpeed Excel/Edge/Elite Select Computed Tomography XRay System
Model / Serial
Gantry model numbers 5191001, 5191002, 5191003, and 5191003-2.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
BrightSpeed Excel/Edge/Elite Select Computed Tomography X-Ray System. || For head, whole body X-ray Computed Tomography applications.
Manufacturer
GE Healthcare, LLC
1 Event
Recall of Device Recall BrightSpeed Excel/Edge/Elite Select Computed Tomography XRay System
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Manufacturer
GE Healthcare, LLC
Manufacturer Address
GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
Manufacturer Parent Company (2017)
General Electric Company
Source
USFDA
Language
English
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