Device Recall GE Precision XR/a

  • Model / Serial
    42948HL0, 42949HL8, 43054HL6, 43055HL3, 43056HL1, 43057HL9, 43132HL0, 43133HL8, 43134HL6, 43135HL3, 43201HL3, 43202HL1, 43203HL9, 44605HL4, 44606HL2, 44607HL0, 44608HL8, 44609HL6, 44610HL4, 44681HL5, 45046HL0, 45047HL8, 45048HL6, 45128HL6, 45129HL4, 45130HL2, 45131HL0, 48119HL2, 48120HL0, 48121HL8, 48122HL6, 48123HL4, 48124HL2, 48125HL9, 48126HL7, 48127HL5, 48128HL3, 48164HL8, 48181HL2, 48274HL5, 48276HL0, 48277HL8, 48278HL6, 48680HL3, 48682HL9, 48683HL7, 48684HL5, 48685HL2, 48686HL0, 48687HL8, 48688HL6, 48689HL4, 48876HL7, 48877HL5, 48878HL3, 48995HL3, 48997HL1, 48998HL9, 49000HL3, 49208HL2, 49209HL0, 49210HL8, 49211HL6, 49391HL6, 49392HL4, 49393HL2, 49395HL7, 49494HL8, 49496HL3, 49497HL1, 49498HL9, 49499HL7, 49500HL2, 49501HL0, 49502HL8, 49503HL6, 49681HL0, 49682HL8, 49683HL6, 49684HL4, 49685HL1, 49686HL9, 49687HL7, 49688HL5, 49850HL1, 49851HL9, 49852HL7, 49853HL5, 49855HL0, 49856HL8, 49857HL6, 50027HL2, 50028HL0, 50029HL8, 50030HL6, 50031HL4, 50177HL5, 50178HL3, 50179HL1, 50180HL9, 50321HL9, 50322HL7, 50323HL5, 50324HL3, 50444HL9, 50445HL6, 50446HL4, 50447HL2, 50448HL0, 50449HL8, 50450HL6, 50451HL4, 50452HL2, 50453HL0, 50790HL5, 50791HL3, 50792HL1, 50793HL9, 50794HL9, 50795HL4, 50797HL0, 50798HL8, 50801HL0, 51143HL6, 51144HL4, 51145HL1, 51147HL7, 51486HL9, 51487HL7, 51488HL5, 52014HL8, and 70RD05001
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including states of CA, DE, FL, GA, ID, IL, KS, KY, MD, MI, MO, MT, NC, NJ, NM, NY, OH, PA, SC, TX, UT, VA, and WV, and countries of Australia, Canada, China, France, Germany, Greece, Italy, Korea, Poland, Saudi Arabia, United Kingdom, and Venezuela.
  • Product Description
    GE Healthcare Proteus XR/a Eclipse Collimator model # 2379827.
  • Manufacturer
  • 1 Event

Manufacturer

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