Device Recall VIGILANCE MONITOR

  • Model / Serial
    Lot Numbers: All devices serialized with software release 5.3 or earlier.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide
  • Product Description
    EDWARDS VIGILANCE MONITORS || (FORMERLY BAXTER VIGILANCE MONITORS) || with software release 5.3 or earlier only. Patient monitor which measures cardiac output. || Models: VG, VGS, VGS1, VGS2, VG2, & IVM.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Edwards Lifesciences Llc, One Edwards Way, Irvine CA 92614-5688
  • Source
    USFDA