Devices

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
  • 1 Event

Manufacturer

GE Healthcare
  • Manufacturer Address
    GE Healthcare, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA

One device with a similar name

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Device Recall GE Healthcare innova 3100IQ
  • Model / Serial
    Model number - 5892935G052G
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution
  • Product Description
    GE Healthcare innova 3100-IQ, Mobile X-ray system || The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally , rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures.
  • Manufacturer
    GE Healthcare, LLC