Device Recall Surgical microscope

  • 모델명 / 제조번호(시리얼번호)
    article 10448196: serial numbers 17091004, 20911002, 26110801, 31207001, 31207002, 61006001, 61006002, 91208002, 101208001, 101210002, 140508002, 151209002, 160806002, 260811001, 261108001 and 261108002;  article 10448197: serial numbers 11010001, 50510002, 81007003, 110507002, 130707001, 130707003, 160910008, 180607001, 230909001, 270407006 and 300307001
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) including states of: California, Connecticut, Kansas, Missouri, New York, North Dakota, Ohio, Pennsylvania, Texas and Utah; and countries of: Japan and South Africa,
  • 제품 설명
    Touch Panel/Control Unit Carrier of the Swingarm M820/M844 C19, article no. 10448194MO; a component of the Leica M820 C19 Surgical Microscope, article 10448196, and the Leica M844 C19 Surgical Microscope, article 10448197; ceiling mounted surgical microscopes; Leica Microsystems (Schweiz) AG, Max Schmidheiny-Strasse 201, CH-9425, Heerbrugg, Switzerland;; The intended use of the microscope is for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Leica Microsystems, Inc., 1700 Leider Ln, Buffalo Grove IL 60089-6622
  • 제조사 모회사 (2017)
  • Source
    USFDA