Device Recall ApexPro FH Telemetry System

  • 모델명 / 제조번호(시리얼번호)
    Software versions v3.8 and earlier.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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

제조사

  • 제조사 주소
    Ge Healthcare, 9900 W Innovation Dr, Wauwatosa WI 53226-4856
  • 제조사 모회사 (2017)
  • Source
    USFDA