MicroGas 7650 Operator Manual used with Radiometer MicroGas 7650 Transcutaneous Monitor 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Radiometer Pacific 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-00617-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-07-09
  • 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
    Radiometer has recently become aware that the storage temperature range for the combi m sensor 82 printed in the operators manual for microgas 7650 is incorrect. the operators manual states that the storage temperature range is -40c to +70c when it should be -10c to +50c as per the information supplied with the product.
  • 조치
    Radiometer is reiterating instructions on how to verify the performance of the sensor. An addendum to the instructions for use is also being provided with the correct storage conditions. This action has been closed-out on 15/08/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    MicroGas 7650 Operator Manual used with Radiometer MicroGas 7650 Transcutaneous MonitorSerial Numbers: All lotsAffects: COMBI M sensor 82 ; Item code: 0605000ARTG Number: 140334
  • Manufacturer

Manufacturer