Device Recall GE Healthcare Brivo XR285amx

  • Model / Serial
    Lot or serial numbers include but not limited to: 00000086177HL3, 00001028564WK1, 115226HL3, 00000083538HL9, 00000092940HL6, 00000084909HL1, 00000081798HL1, 120634HL1, 00000084729HL3, 00000084161HL9, 00000082463HL1, 00000080868HL3, 120832HL1, 00000089868HL4, 00000082736HL0, 00000093379HL6, 00000092616HL2, 00000092633HL7, 00000081160HL4, 00000077253HL3, 00000076913HL3, 00000078498HL3, 00000084160HL1, 00000078315HL9, 00000082726HL1, 00000085039HL6, 00000080635HL6, 00000091403HL6, 00000085598HL1, 00000085661HL7, 00000077923HL1, 00000081481HL4, 00001027046WK0, 00000081152HL1, 00000086364HL7, 00000092622HL0, 00000085000HL8, 00000084999HL2, 00000084725HL1, 00000083029HL9, 00000078313HL4, 00000084162HL7, 00000083020HL8, 00000077471HL1, 00000083019HL0, 00000082738HL6, 00000083598HL3, 00000092618HL8, 00000084180HL9, 00000085594HL0, 00000084917HL4, 00000076790HL5, 00000091413HL5, 00001028931WK2, 00000102856WK4, 00001028927WK0, 00001028924WK7, 00000084159HL3, 00000084422HL5, 00001029525WK1, 00000077482HL8, 00000082250HL2, 00000075962HL1, 00000079632HL6, 00000082240HL3, 00000081484HL8, 00000084732HL7, 00000077924HL9, 00000079918HL9, 00000082247HL8, 00000082245HL2, 00000082243HL7, 00000077255HL8, 00000086373HL8, 00000087093HL1, 00000102539HL4, 00000085004HL0, 00000085599HL9, 00000079559HL1, 00000079282HL0, 00000077782HL1, 00000082480HL5, 00000079116HL0, 00001028894WK2, 00000078317HL5, 00000079280HL4, 00000129740WG7, 00000079278HL8, 00000078492HL6, 00000075947HL2, 00000084908KL3, 00000084412HL6, 00000084169HL2, 00001027692WK1, 00000085036HL2, 0000000012C559, 00000084178HL3, 00000093852HL2, 00000092058HL7, 00000087079HL0, 00001029020WK3, 00001028888WK4, 00001028659WK9, 00001028662WK3, 00001028661WK5, 00000086380HL3, 00001028660WK7, 00000084172HL6, 00001028595WK5, 00000086365HL4, 00000084411HL8, 00000084402HL7, 00000084906HL7, 00001028866WK0, 00001028925WK4, and 00000085034HL7.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, including Washington D.C. Puerto Rico, Virgin Islands, and Guam; and the countries of Afghanistan, Albania, Anguilla, Antigua and Barbuda, Armenia, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt, Ethiopia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, Iceland, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea (Republic of), Kuwait, Lebanon, Malaysia, Martinique, Mexico, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Papua New Guinea, Paraguay, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Trinidad , Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
  • Product Description
    GE Healthcare, Brivo XR285amx Mobile Digital Ready Radiographic System || Designed to generate diagnostic radiographic images.
  • Manufacturer
  • 1 Event

Manufacturer

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