Events

Transpac 4 Disposable Pressure Transducer Monitoring Kit 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Philips Electronics Australia 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-00015-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-01-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00015-1
  • 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
    Certain lots of the transpac 4 disposable pressure transducer monitoring kit may have the potential to leak or potentially introduce small amounts of air into the line. this could result in potential harm to the patient due to blood loss, introduction of air into the line or contamination of intravenous fluid. there is also potential harm to the user as a result of exposure to blood borne pathogens.
  • 조치
    Philips is advising users to discontinue use of affected products and to check their inventory for affected stock. Affected stock is to be quarantined and users are requested to contact Philips prior to returning the affected products in order to receive a credit. This action has been closed-out on 01/03/2018.

Device

Transpac 4 Disposable Pressure Transducer Monitoring Kit
  • 모델명 / 제조번호(시리얼번호)
    Transpac 4 Disposable Pressure Transducer Monitoring KitProduct Number: 989803177901Lot Numbers: 3239500, 3247905Product Number: 989803194641Lot Number: 3258299ARTG Number: 197576
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • 제조사 모회사 (2017)
    Philips
  • Source
    DHTGA