Device Recall ROSA(TM) Robotized Stereotactic Assistant

  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: RO 10 009, RO 10 011, RO 10 014, RO 13 023, RO 13 027, RO 14 031, RO 14 033, RO 14 035, RO 14 038, RO 14 039, RO 14 040, RO 14 041, RO 14 043, RO 15 044, RO 15 045, RO 15 046, RO 15 050, RO 15 051, RO 15 052, RO 15 053, RO 15 054, RO 15 058, RO 15 059, RO 15 060, RO 15 061, RO 15 063, RO 15 064, RO 15 067, RO 15 069
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution
  • 제품 설명
    ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 || ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    MEDTECH SAS, Parc Euromedecine Batiment 8, 1006 rue de la Croix Verte, Montpellier France
  • 제조사 모회사 (2017)
  • 제조사 의견
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA