Devices

Device Recall GE Healthcare Innova 3100 / 3100 IQ

Model / Serial
82416120006, 4103323100, 82416120005, and 214324INNOVA2
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- USA including states of MD, TX, and VA and country of China.
Product Description
GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) || Indicated for use in diagnostic and interventional angiographic procedures of human anatomy. Intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. Not intended for mammography applications.
Manufacturer
GE Medical Systems, LLC
1 Event
- Recall of Device Recall GE Healthcare Innova 3100 / 3100 IQ

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

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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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