Device Recall ApexPro FH Telemetry System

  • Model / Serial
    Software versions v3.8 and earlier.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution --- including states of AL, AR, AZ, CA, CO, Washington DC, FL, IL, IN, ME, MI, MN, MO, NC, NE, NJ, NY, OK, PA, SC, TX, VA, WA, WI, WV.
  • Product Description
    ApexPro FH Telemetry System: composed of six major components (as follows); Accessories to the patient worn acquisition transceivers, the patient worn data acquisition transceivers, the transceiver access points with antenna, the network infrastructure, A computer platform running the ApexPro Telemetry Application and a computer platform running a central station application (which may be the same computer platform running the ApexPro Telemetry Application). GE Medical Systems information Technologies, 8200 West Tower Avenue, Milwaukee, WI 53223.
  • Manufacturer
  • 1 Event

Manufacturer

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