Devices

Device Recall Innova 3100IQ (Optima Edition) Fluoroscopic Vascular Xray System

Model / Serial
00000002010011 599032BU0 00000002011001 00000002011002 598347BU3 00000002010013 00000002010017 00000002010012 00000002010014 00000002010015 599038BU7 00000002010016 00000002010010 00000002011003 00000002010007
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- USA, including the states of TX & NC and the countries of TURKEY, POLAND, MEXICO, CHINA, CAMBODIA, BRAZIL, BOLIVIA, and SAUDI ARABIA.
Product Description
GE Healthcare, Innova¿ 3100IQ (Optima Edition) Fluoroscopic Vascular X-ray System. || Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging-procedures.
Manufacturer
GE Healthcare, LLC
1 Event
- Recall of Device Recall Innova 3100IQ (Optima Edition) Fluoroscopic Vascular Xray System

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

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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