Devices

Device Recall GE Healthcare, Innova

Model / Serial
0000008C2M0006 0000008C2M0003 0000009C2M0029 0000009C2M0014 0000009C2M0028 0000009C2M0057 0000009C2M0049 0000009C2M0013 0000009C2M0040 0000009C2M0025 0000009C2M0023 0000009C2M0041 0000009C2M0021 0000009C2M0046 0000009C2M0033 0000009C2M0058 0000009C2M0053 0000009C2M0056 0000009C2M0060 0000009C2M0150 0000009C2M0062 0000009C2M0009 0000009C2M0030 0000009C2M0064 0000009C2M0054 0000009C2M0042 0000009C2M0068 0000009C2M0059 0000009C2M0010 0000009C2M0016 0000009C2M0074 0000009C2M0096 0000009C2M0088 0000009C2M0090 0000009C2M0104 0000009C2M0077 0000009C2M0063 0000009C2M0148 0000009C2M0101 0000009C2M0067 0000009C2M0157 0000009C2M0156 0000009C2M0175 0000009C2M0111 0000009C2M0120 0000009C2M0128 0000009C2M0127 0000009C2M0131 0000009C2M0130 0000009C2M0147 0000009C2M0097 0000009C2M0110 0000009C2M0118 0000009C2M0192 0000009C2M0119 0000009C2M0160 0000009C2M0177 0000009C2M0205 0000009C2M0209 0000010C2M0011 0000009C2M0071 0000009C2M0178 0000009C2M0185 0000009C2M0082 0000009C2M0081 0000009C2M0126 0000009C2M0122 0000009C2M0180 0000009C2M0197 0000009C2M0109 0000009C2M0112 0000009C2M0115 0000010C2M0002 0000010C2M0006 0000009C2M0139
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA, Puerto Rico, VENEZUELA, UNITED KINGDOM, TURKEY, THAILAND, TAIWAN, PROVINCE OF CHINA, SWEDEN, SPAIN, RUSSIAN FEDERATION, ROMANIA, POLAND, PHILIPPINES, NORWAY, NETHERLANDS, MOROCCO, REPUBLIC OF KOREA, KAZAKSTAN, JAPAN, ITALY, ISLAMIC REPUBLIC OF IRAN, INDONESIA, INDIA, GERMANY, FRANCE, FINLAND, EGYPT, CHINA, CHILE, CANADA, BRAZIL, BELGIUM, BELARUS, AUSTRALIA, and ARGENTINA.
Product Description
GE Healthcare, Innova 3100 IQ : GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)
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

3 devices with a similar name

Learn more about the data here

Device Recall GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ

Model / Serial
SERIAL NUMBER 592043BU4 592676BU1 593459BU1 593465BU8 592458BU4 592673BU8 592682BU9 593059BU9 593051BU6 593475BU7 593476BU5 592049BU1 593468BU2 593054BU0 592047BU5 592042BU6 592046BU7 592459BU2 593048BU2 593056BU5 593049BU0 593063BU1 593062BU3 593464BU1 594762BU7 593473BU2 592451BU9 593460BU9 597954BU7 592456BU8 592674BU6 593052BU4 593058BU1 590867BU8 592050BU9 593064BU9 592460BU0 592457BU6 592680BU3 592455BU0 593462BU5 592678BU7 594763BU5 593055BU7 592675BU3 592452BU7 593463BU3 594385BU7
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution-USA including the states of FL, IL, IN, NJ, NC, OK, TX, and WI, and the countries of UNITED KINGDOM, TUNISIA, SERBIA, RUSSIAN FEDERATION, NORWAY, NIGERIA, LITHUANIA, LEBANON, KOREA, REPUBLIC OF KOREA, ITALY, INDONESIA, INDIA, FRANCE, FINLAND, COLOMBIA, CHINA, and BRAZIL.
Product Description
GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-ray imaging || systems. || For use in generating fluoroscopic images of human anatomy.
Manufacturer
GE Healthcare, LLC

Device Recall GE Healthcare, Innova 3100 and Innova 4100 systems

Model / Serial
SERIAL NUMBER 00000007C20103 0000010C2M0069 0000010C2M0181 0000010C2M0214 0000010C2M0259 0000010C2M0137 0000010C2M0159 0000010C2M0262 0000009C2M0084 0000010C2M0130 0000010C2M0218 0000010C2M0297 0000009C2M0108 0000010C2M0236 0000009C2M0167 0000010C2M0208 0000010C2M0295 0000000DUMMY01 00000009C20099 00000007C20141 00000595660BU2 0000010C2M0063 0000010C2M0083 0000009C2M0041 0000010C2M0180 0000010C2M0189 0000010C2M0174 00000593054BU0 00000007C20150 0000010C2M0027 0000010C2M0121 0000010C2M0229 0000010C2M0253 0000010C2M0122 0000010C2M0005 00000007C20173 0000009C2M0040 0000009C2M0077 0000010C2M0088 0000010C2M0097 0000010C2M0143 0000010C2M0192 0000010C2M0193 0000010C2M0204 0000010C2M0294 0000010C2M0269 0000010C2M0176 00000498682BU4
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution - USA including AZ, CA, CO, FL, ID, IL, ME, NV,NY, NC, OK, TN, UT, and WI; and Internationally to Canada, Chile, France, Germany, Italy, Japan, Korea, Norway and Spain.
Product Description
GE Healthcare, Innova 3100 and Innova 4100 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.
Manufacturer
GE Healthcare, LLC

Device Recall GE Healthcare, Innova

Model / Serial
0000009C2M0037 0000009C2M0007 00000008C2M001 0000009C2M0032 0000009C2M0154 0000009C2M0065 0000009C2M0072 0000009C2M0078 0000009C2M0084 0000009C2MOO84 0000009C2M0085 0000009C2M0143 0000009C2M0136 0000009C2M0163 0000009C2M0100 0000009C2M0162 0000009C2M0117 0000009C2M0167 0000009C2M0093 0000009C2M0166 0000009C2M0171 0000009C2M0187 0000009C2M0144 0000009C2M0106 0000009C2M0199 0000009C2M0200 0000010C2M0005 0000009C2M0024
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA, Puerto Rico, VENEZUELA, UNITED KINGDOM, TURKEY, THAILAND, TAIWAN, PROVINCE OF CHINA, SWEDEN, SPAIN, RUSSIAN FEDERATION, ROMANIA, POLAND, PHILIPPINES, NORWAY, NETHERLANDS, MOROCCO, REPUBLIC OF KOREA, KAZAKSTAN, JAPAN, ITALY, ISLAMIC REPUBLIC OF IRAN, INDONESIA, INDIA, GERMANY, FRANCE, FINLAND, EGYPT, CHINA, CHILE, CANADA, BRAZIL, BELGIUM, BELARUS, AUSTRALIA, and ARGENTINA.
Product Description
GE Healthcare, Innova 4100 IQ: GE Innova 4100 / 4100 IQ., Cardiovascular Imaging System (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)
Manufacturer
Ge Healthcare, Llc

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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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