Events

Tourniquet Systems 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Zimmer Surgical, 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
    21816
  • 사례 시작날짜
    2017-08-14
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Zimmer Biomet New Zealand Company, 210 Khyber Pass Road, Grafton, Auckland
  • 원인
    In a typical or setting, the manufacturer originally recommended a minimum separation distance of 3.8 meters (m) between rf communication equipment to mitigate the potential for electromagnetic interference and to achieve optimal performance of the tourniquet machines. rf equipment consists of, but is not limited to, electrosurgical equipment, including any consoles, wiring, and pencil units. this distance recommendation originates from iec 60601-1-2. as a result of customer feedback, additional internal testing was performed to see if this distance could be shortened, and it was determined that 1.0 meter provided adequate distance to avoid interference.
  • 조치
    Instructions for use to be updated

Device

Tourniquet Systems
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: updating an on-device label on ATS2200 and ATS4000 units
  • Manufacturer
    Zimmer Surgical, Inc.

Manufacturer

Zimmer Surgical, Inc.
  • 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
    NZMMDSA