The Implant Files -
International Medical Devices Database
- About this investigation
- International Medical Devices Database
- Tell us your story
- Resources for patients
- Reporting partners
- Video introduction
Stories - Patients harmed by medical devices
- Europe, a device gateway to the world
- History of the industry
- The Medtronic way
- Ruptured trust and breast implants
- Heart device raises risk questions
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Model / Serial
With Gantry model numbers 2200997, 2200997-2, 2201000, 2201000-2, 2249696 and 2249696-2.
- Product Classification
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Device Class
2
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Implanted device?
No
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Distribution
Nationwide Distribution
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Product Description
HiSpeed FX/I (2201000-2 with Gantry mo. #2249696-2)
- Manufacturer
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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
Manufacturer
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Manufacturer Address
GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
- Manufacturer Parent Company (2017)
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Source
USFDA