Events

Device Recall ROSA 3.0 (Brain application) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Zimmer Biomet, Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    78944
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0638-2018
  • 사례 시작날짜
    2017-05-01
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160939
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Neurological stereotaxic Instrument - Product Code HAW
  • 원인
    Robot arm being sent to the wrong position.
  • 조치
    Urgent Medical Device Recall (Correction) notices were sent to customers. The letter provided to hospital risk managers and surgeons identified the issue and their responsibilities. These responsibilities included: - Stop using the micromovement function in isocentric mode during Brain Surgery with ROSA Brain 3.0 device. -Reviewing the notification to ensure comprehension of the steps required to be taken prior to the permanent correction that will be implemented on site by a service engineer. - Completing and returning Attachment 1 (Certificate of Acknowledgement) to the e-mail address provided. The firm has prepared a software correction that will be deployed and implemented on site by a MEDTECH representative.

Device

Device Recall ROSA 3.0 (Brain application)
  • 모델명 / 제조번호(시리얼번호)
    BR16005, BR16004, BR16006, BR16012, BR16011, BR16009, BR16010, BR16014, BR16013, BR16015, BR16021, BR16017, BR16018, BR16016,  BR16023, and BR16025.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed to CA, DC, FL, IL, KY, MA, MN, NC, NY, OH, and PA.
  • 제품 설명
    ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. || Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons.
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • 제조사 주소
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 제조사 모회사 (2017)
    Zimmer Biomet Holdings
  • 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