Artis Dialysis Systems - 230V, 230V Physio & 230 V Physio I 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Baxter Healthcare 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-00494-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-04-27
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    Baxter healthcare is issuing a device correction for specific models of the artis dialysis systems in order to update the current software versions to the new software versions. the current version allows for the possibility of resetting and continuing patient treatment without following the instructions for addressing alarm #642, “arterial chamber: level adjustment required.” this will subsequently deactivate the alarm for the remaining treatment time. the new software versions prevent the possibility of continuing the treatment without following the instructions for addressing alarm #642, as detailed in the operator’s manual. users of these devices should adhere to the instructions provided in the current operator’s manual for addressing alarm #642.
  • 조치
    Clinicians may continue to safely use the affected Artis dialysis systems provided they utilise additional vigilance to adhere to the instruction for use for addressing Alarm #642, as documented in the Operator’s Manual until the software correction can be provided to the relevant facilities.

Device

  • 모델명 / 제조번호(시리얼번호)
    Artis Dialysis Systems - 230V, 230V Physio & 230 V Physio IProduct Codes: 110635, 115323 and 115147All Serial NumbersARTG Number: 141189
  • Manufacturer

Manufacturer