Devices

Device Recall GE Healthcare Innova

  • 모델명 / 제조번호(시리얼번호)
    Innova 2100, 3100, 4100, 2121, and 3131
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA Nationwide Distribution
  • 제품 설명
    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

제조사

GE Healthcare, LLC
  • 제조사 주소
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 20 건

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Device Recall GE Healthcare Innova 2100IQ
  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    Serial Number System ID 0000011BC20026 2192632121
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    Serial Number System ID 0000010C2M037O 620272INNOVA31 0000009C2M0192 X98766705 00000464106BU4 A5127281 00000007C20175 RU2741VA01 0000013C2S0087 082416100052 0000010C2M0299 082416100030
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    Serial Number System ID 005178429-0176 561881BP1 0000010BC20004 B5114298
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    Serial Number System ID 0000013C2S0065 302421IGS520 15C2R0058 LVIGS2 15C2R0065 AM1396F508 15C2R0082 206598UIGS 15C2R0092 AM135FE37 0000015C2R0062 HU1117VA01 0000015C2R0057 083016848125215 0000015C2R0069 5512XR0026  0000015C2R0060 00632VAS01 0000015C2R0080 00391VAS02
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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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