Device Recall iDXA

  • Model / Serial
    software versions 12.0, 12.1, 12.2,13.0, & 13.1.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    iDXA, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1. || The systems provide an estimate of BMD
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Ge Healthcare, 9900 W Innovation Dr, Wauwatosa WI 53226-4856
  • Manufacturer Parent Company (2017)
  • Source
    USFDA