Events

ADVIA Chemistry Halogen Lamp 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens 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-2015-RN-01148-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2015-11-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01148-1
  • 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
    Siemens healthcare diagnostics is conducting a recall for product correction for the advia chemistry halogen lamp (smn 10309448) in advia chemistry systems. siemens has identified specific lot numbers of the halogen lamp that may have a defect that could cause it to fail prematurely.The potential exists for a delay in testing if the halogen lamp fails prematurely. results are not impacted as the system will become inoperable when this issue occurs. the risk to health is low. siemens is not recommending a laboratory look back as a result of this issue.
  • 조치
    The sponsor Siemens is advising users to inspect unused stock and discard affected units. The sponsor will replace the affected units. If the Halogen lamp currently installed in the system fails approximately 100 hours after installation, customers are to contact the sponsor for a replacement. This action has been closed-out on 24/05/2017.

Device

ADVIA Chemistry Halogen Lamp
  • 모델명 / 제조번호(시리얼번호)
    ADVIA Chemistry Halogen LampSiemens Material Number (SMN): 10309448Affected Lot Numbers: J411, J412, J501, J502, J503, J504, J505, J506Affected ADVIA Chemistry Systems:ADVIA 1200SMN: 10309735, 10470358, Legacy Numbers – 094-A001-02, 094-A001-03, 094-A001-04, 094-A001-05, 094-A001-06ADVIA 1800SMN: 10315183, 10322655, 10337372, 10337373, 10337374, 10337375, 10337376ADVIA 2400SMN: 10315769, 10816871, 10816872, 10816873, 10816874, 10816875, 10816876ARTG Number: 175890
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd