Events

Siemens Dimension Vista V-LYTE Intergrated Multisensor 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Siemens Healthcare Diagnostics 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
    20972
  • 사례 시작날짜
    2017-02-01
  • 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: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • 원인
    The manufacturer has confirmed a low bias for dimension vista v-lyte integrated multisensor urine potassium (k) when compared to the dimension quiklyte integrated multisensor, which is the predicate device used in the method comparison section of the v-lyte instructions for use (ifu). our testing showed a bias of -4.9% at a urine potassium concentration of 39.6 mmol/l, -19.6% at a urine potassium concentration of 32.8 mmol/l, and an average bias of -10.9% over the urine potassium concentration range of 7.5 to 133.7 mmol/l. this bias affects patient results, qc and could result in failures in accuracy-based proficiency testing program., the manufacturer is issuing this follow-up notification with enhanced instructions for updating and verifying the urine potassium method comparison coefficients.
  • 조치
    Software to be upgraded

Device

Siemens Dimension Vista V-LYTE Intergrated Multisensor

Manufacturer

Siemens Healthcare Diagnostics Inc