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Device Recall HiSpeed FX/I
Model / Serial
With Gantry model numbers 2200997, 2200997-2, 2201000, 2201000-2, 2249696 and 2249696-2.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
HiSpeed FX/I (2201000-2 with Gantry mo. #2249696-2)
Manufacturer
GE Healthcare, LLC
18 Events
Recall of Device Recall HiSpeed FX/I
Recall of Device Recall HiSpeed FX/I
Recall of Device Recall HiSpeed FX/I
Recall of Device Recall HiSpeed FX/I
Recall of Device Recall HiSpeed FX/I
Recall of Device Recall HiSpeed FX/I
Recall of Device Recall HiSpeed FX/I
Recall of Device Recall HiSpeed FX/I
Recall of Device Recall HiSpeed FX/I
Recall of Device Recall HiSpeed FX/I
Recall of Device Recall HiSpeed FX/I
Recall of Device Recall HiSpeed FX/I
Recall of Device Recall HiSpeed FX/I
Recall of Device Recall HiSpeed FX/I
Recall of Device Recall HiSpeed FX/I
Recall of Device Recall HiSpeed FX/I
Recall of Device Recall HiSpeed FX/I
Recall of Device Recall HiSpeed FX/I
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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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