Events

V-Sign Sensor 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Temple 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-00355-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-05-01
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00355-1
  • 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
    Based on high customer complaint rates sentec has identified three production batches of v-sign sensors where the pco2-measuring element shows signs of pre-mature aging; in some cases already after 4 to 11.5 months of use resulting in loss of pco2-monitoring function.This action was undertaken prior to notifying tga.
  • 조치
    Temple Helathcare (local SenTec distributor) is contacting all the affected customers and replacing the sensor free of charge in return for the affected sensor. This action has been closed-out on 15/02/2016.

Device

V-Sign Sensor
  • 모델명 / 제조번호(시리얼번호)
    V-Sign SensorSerial numbers: 315.592, 315.593, 315.595 & 315.596
  • Manufacturer
    Temple Healthcare Pty Ltd

Manufacturer

Temple Healthcare Pty Ltd