Device Recall Xray system

  • Model / Serial
    Serial numbers beginning with T2 and T9
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. Foreign distribution to Argentina, Australia, Austria, Canada, Germany, Italy, Japan, Mexico, Russia and Switzerland.
  • Product Description
    Uroview 2000 X-ray System
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    GE OEC Medical Systems,Inc, 384 Wright Brothers Drive, Salt Lake City UT 84116
  • Source
    USFDA

3 devices with a similar name

Learn more about the data here

  • Model / Serial
    Serial numbers beginning with M2 and M9.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. Foreign distribution to Argentina, Australia, Austria, Canada, Germany, Italy, Japan, Mexico, Russia and Switzerland.
  • Product Description
    Uroview 2500 X-ray System
  • Manufacturer
  • Model / Serial
    Serial numbers beginning with W2 and W9.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. Foreign distribution to Argentina, Australia, Austria, Canada, Germany, Italy, Japan, Mexico, Russia and Switzerland.
  • Product Description
    Uroview 2600 Uroview System
  • Manufacturer
  • Model / Serial
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A5333037 00000608125BU1 A5365426 0000010C2M0154 A5401383 00000591390BU0 A5719853 0000010C2M0164 A5810824 00000463078BU6 A5697709 00000493966BU6 XF0153 00000564505BU6 YV0013 00000438669BU4 YV0022 00000439612BU3 YV0023 00000478097BU9 YV0035 00000547029BU9 YV0076 00000514380BU5 YX1483 00000459461BU0 YV0030 00000560738BU7 YV0363 00000612546BU2 YV0388 00000454589BU3 JO1000VA01 00000600863BU5 0850060744 00000560740BU3 0834160005 FMI12204DUMM01 28626INNOVA 00000445752BU9 477XVIN2553211 00000522945BU5 644INNOVA21 00000459368BU7 0920169006 00000435051BU8 NO1005VA05 0000009C2M0125 0843160016 00000476720BU8 600042VA02 00000441173BU2 787653INNOVA FMI12204DUMM02 RU1138VA01 00000551948BU3 RU3053VA01 00000418618BU5 SA1188VA03 00000589400BU1 MEX68922 0000010C2M0176 MEX68928 00000593472BU4 083016808780010 00000580432BU3 34078VAS01 00000537448BU3 60001VAS01 00000428165BU5 00171VAS01 00000462909BU3 00234VAS01 00000424824BU1 77137VAS01 00000483163BU2 00282VAS02
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, ME, MD, MA, MI, MS, MO, NV, NJ, NY, NC, ND, OH, OK OR, PA, PR, RI, SC, TN, TX, UT, VA,WA,WY and WI., and the countries of ARGENTINA, AUSTRALIA, CANADA, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, HUNGARY, INDIA, IRELAND, ITALY, JAPAN, JORDAN, REPUBLIC OF KOREA, MALAYSIA, MEXICO, NEW ZEALAND, NORWAY, PHILIPPINES, POLAND, RUSSIA, SAUDI ARABIA, SPAIN, SRI LANKA, TURKEY and UNITED KINGDOM.
  • Product Description
    GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innova 2121IQ, Innova 3131IQ; Cardiovascular X-ray imaging systems (X-ray generator installed with Rotor V3 version and Heater V4 version boards). || The Digital Fluoroscopic Imaging System is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and intervention angiography procedures. It is intended to replace fluoroscopic images obtained through the image intensifier technology. This device is not intended for mammography applications. The Innova 3100 system is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, and optionally, rotational and angiography procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. 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. A new tilt table will support performing procedures like CO2 studies, Venography. The Digital Fluoroscopic Imaging System with Bolus Chasing option is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and intervention; the option Bolus enables to perform subtraction angiography of lower limbs. This device is not intended for mammography applications. The Innova 2100-IQ system is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures, and optionally, rotational angiography procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology diagnostic and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. This device is not intended for mammography applications. For Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100 IQ, Innova 2100IQ with Innova 3T Option: The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications. Innova CT is a software option, which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to provide images that assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up. Innova CT is intended for imaging bone and soft tissues as well as other internal body structures. Innova CT is not intended for mammography applications. For Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100 IQ, Innova 2100IQ with Innova 3D or InnovaSpin option: The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications. Innova 3D is a software option which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up. It is not intended for mammography applications. InnovaSpin is a software option that permits fast spin rotational angiography. It is not intended for mammography applications. :
  • Manufacturer