Device Recall EasyLink(TM) Informatics Systems

  • 모델명 / 제조번호(시리얼번호)
    Catalog number 1000034805
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (nationwide) and the countries of CANADA, FRANCE, GERMANY, SPAIN, PORTUGAL, ITALY, JAPAN, NORWAY, AUSTRALIA, AUSTRIA, NEW ZEALAND, BELGIUM, SWITZERLAND, NETHERLANDS, MALAYASIA, SLOVENIA, SOUTH KOREA, DENMARK, SAUDI ARABIA, SLOVAKIA, PUERTO RICO, INDONESIA and TAIWAN.
  • 제품 설명
    EasyLink(TM) Informatics Systems Software Version 5.0 and Software Version 5.0 Service Packs 1 through 4 used with the Dimension Vista(R) System. || The EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostics devices. The EasyLink(TM) is included with the Dimension Vista(R) System, and may be used with other Siemens analyzers, as a communications and connectivity workstation for integration with laboratory information system (LIS) networks. || Product Quantity Distributed (Int) 787
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • 제조사 모회사 (2017)
  • Source
    USFDA