Device Recall RM, RMAT

  • 모델명 / 제조번호(시리얼번호)
    Model No. L9M2100; Software Versions RM 2.08.12.00.00. All versions of the CV Reporting (RM) are now affected.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    AK, AZ, CA, CO, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, MS, MT, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, VA, WA, WV, WI and Canada
  • 제품 설명
    IMPAX CV Results Manager/Results Manager Administration Tool
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    AGFA Corp., 10 S Academy St, Greenville SC 29601-2632
  • Source
    USFDA