Devices

Device Recall GE Healthcare Innova

Model / Serial
Innova 2100, 3100, 4100, 2121, and 3131
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
USA Nationwide Distribution
Product Description
GE Healthcare Innova X-ray Imaging Systems. || The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. This device is not intended for mammography applications.
Manufacturer
GE Healthcare, LLC
1 Event
- Recall of Device Recall GE Healthcare Innova

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

20 devices with a similar name

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Device Recall GE Healthcare Innova 2100IQ

Model / Serial
Serial Number System ID 00000465837BU3 610776INNOVA21 00000007C20214 760940INNOVA2 00000008C20031 083016842102488 00000007C20126 083016242100487 00000459677BU1 00888VAS02 0000011C2M0208 727869EP4 0000009C2M0034 083016608167379 0000009C2M0022 083016202100349 Not Available 0835160049 0000012C2S0028 A5403911 00000464565BU1 M2844529 0000011BC20026 2192632121 FMI12181DUMM17 082416270004 00000466838BU0 082416160007
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: US (nationwide) including states of: CA, DE, FL, GA, IL, IN, KS, MS, NV, OH, OK, OR, PA, TN, TX, VA, WA and WI; and countries of: ARGENTINA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, INDONESIA, ITALY, JAPAN, RUSSIA, UNITED KINGDOM, and VIETNAM.
Product Description
GE Healthcare Innova 2100IQ. || Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Manufacturer
GE Healthcare

Device Recall GE Healthcare Innova 2121IQ

Model / Serial
Serial Number System ID 0000011BC20026 2192632121
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: US (nationwide) including states of: CA, DE, FL, GA, IL, IN, KS, MS, NV, OH, OK, OR, PA, TN, TX, VA, WA and WI; and countries of: ARGENTINA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, INDONESIA, ITALY, JAPAN, RUSSIA, UNITED KINGDOM, and VIETNAM.
Product Description
GE Healthcare Innova 2121IQ. || Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Manufacturer
GE Healthcare

Device Recall GE Healthcare Innova 3100IQ

Model / Serial
Serial Number System ID 0000010C2M037O 620272INNOVA31 0000009C2M0192 X98766705 00000464106BU4 A5127281 00000007C20175 RU2741VA01 0000013C2S0087 082416100052 0000010C2M0299 082416100030
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: US (nationwide) including states of: CA, DE, FL, GA, IL, IN, KS, MS, NV, OH, OK, OR, PA, TN, TX, VA, WA and WI; and countries of: ARGENTINA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, INDONESIA, ITALY, JAPAN, RUSSIA, UNITED KINGDOM, and VIETNAM.
Product Description
GE Healthcare Innova 3100IQ. || Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Manufacturer
GE Healthcare

Device Recall GE Healthcare Innova 3131IQ

Model / Serial
Serial Number System ID 005178429-0176 561881BP1 0000010BC20004 B5114298
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: US (nationwide) including states of: CA, DE, FL, GA, IL, IN, KS, MS, NV, OH, OK, OR, PA, TN, TX, VA, WA and WI; and countries of: ARGENTINA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, INDONESIA, ITALY, JAPAN, RUSSIA, UNITED KINGDOM, and VIETNAM.
Product Description
GE Healthcare Innova 3131IQ. || Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Manufacturer
GE Healthcare

Device Recall GE Healthcare Innova IGS 520

Model / Serial
Serial Number System ID 0000013C2S0065 302421IGS520 15C2R0058 LVIGS2 15C2R0065 AM1396F508 15C2R0082 206598UIGS 15C2R0092 AM135FE37 0000015C2R0062 HU1117VA01 0000015C2R0057 083016848125215 0000015C2R0069 5512XR0026 0000015C2R0060 00632VAS01 0000015C2R0080 00391VAS02
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: US (nationwide) including states of: CA, DE, FL, GA, IL, IN, KS, MS, NV, OH, OK, OR, PA, TN, TX, VA, WA and WI; and countries of: ARGENTINA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, INDONESIA, ITALY, JAPAN, RUSSIA, UNITED KINGDOM, and VIETNAM.
Product Description
GE Healthcare Innova IGS 520. || Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Manufacturer
GE Healthcare

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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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