Device Recall Proteus XR/a

  • Model / Serial
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including PR. DC, GUAM, all states except VT. Internationally to the following countries: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BENIN, BOSNIA AND HERZEGOVINA, BOTSWANA, BRAZIL, BULGARIA, BURKINA FASO, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNGRY, ICELAND, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMHIRIYA, LITHUANIA, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, PAKISTAN, PANAMA, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TUNISIA, TURKEY, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM YEMEN.
  • Product Description
    GE Healthcare, Proteus XR/a. || Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
  • Manufacturer
  • 2 Events

Manufacturer

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

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    all serial numbers
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    globally
  • Product Description
    Proteus XR/a Radiographic X-ray System, models 2259973-1, 2259973-2, 2259973-3, 2259973-4. The system consists of a radiographic table, a overhead tube suspension, high frequency generator and power distribution unit, wall stand, dual focal spot x-ray tube and operator''s console.
  • Manufacturer
  • Model / Serial
    30920HL3, 30921HL1, 31931HL9, 3457OHL2, 34864HL9, 34911HL8, 35136HL1, 35191HL6, 35244HL3, 35936HL4, 36207HL9, 36361HL4, 36431HL5, 36521HL3, 36702HL9, 36704HL5, 37009HL8, 37261HL5, 37395HL1, 37396HL9, 37597HL2 & 993702WK0
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide; including states of WA,KS, CO, NM, NC, FL, MT, AZ, TX, IL, NY, MD, and GA
  • Product Description
    GE Healthcare Proteus XR/a General Purpose Radiographic System, Models 2259973-4 and 2380179 containing Proteus Operator Console model# 2259976.
  • Manufacturer