Events

A.T.S. 2200 and A.T.S. 4000 Tourniquet Systems 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Zimmer Biomet Pty Ltd 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
    RC-2017-RN-01068-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2017-08-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01068-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Zimmer biomet has received a total of 14 complaints that the ats 2200 spontaneously inflates the secondary cuff without any user input. zimmer biomet is providing an on-device label and an updated operator/service manual. a medical device corrective action for the ats 2200 and ats 4000 tourniquet systems is being implemented utilising a shortened separation distance of 1.0 metre between rf communication equipment, in order to mitigate the potential for electromagnetic interference and achieve optimal performance of the tourniquet machines.There have been no injuries or deaths reported to date as a result of this issue.
  • 조치
    Zimmer is requesting that customers: 1.Review the notification and ensure affected personnel are aware of the contents; 2.Confirm the receipt of the on-device label and 3 pages of the updated Operator/Service Manual provided with the customer letter; 3.Place the label on the device in the specified location; 4.Replace the 3 pages of the Operator/Service Manual with the updated pages; and 5.Email a completed copy of the supplied Attachment 1 form to RAQA.ANZ@Zimmerbiomet.com to confirm that they have placed the label in the specified location on the device and replaced the 3 pages of the Operator/Service Manual with the updated pages.

Device

A.T.S. 2200 and A.T.S. 4000 Tourniquet Systems
  • 모델명 / 제조번호(시리얼번호)
    A.T.S. 2200 and A.T.S. 4000 Tourniquet SystemsATS2200TS with hosesItem Number: 60-2200-101-00Serial Number (prefix only): 2214-2216ATS4000TS with hosesItem Number: 60-4000-101-00Serial Number (prefix only): 4014-4016ARTG Number: 95696
  • Manufacturer
    Zimmer Biomet Pty Ltd

Manufacturer

Zimmer Biomet Pty Ltd
  • 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
    DHTGA