Device Recall Agfa IMPAX HeartStation ECG Management System

  • 모델명 / 제조번호(시리얼번호)
    Model number HeartStation 1.1 60+00091179 to 60+0091186; HeartStation Core Server 60+00091211; CV HeartStation EZKT7000, L9NBN000, EZKC000, L9NAL000, EZKWE000 and L9M9G000.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    CA, KY, MA, NY, OH, SC, Belgium, Italy and Singapore
  • 제품 설명
    AGFA IMPAX HeartStation ECG Management System.
  • Manufacturer
  • 1 Event

제조사

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