Events

Nordic Neuro Lab Headphones used with Siemens MRI systems 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-2017-RN-00761-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-06-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00761-1
  • 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
    The manufacturer nordic neuro lab has been notified that a set of the headphone slim (hps) heated on the 1.5t scanner during an mri spinal examination, causing damage to the hps headphones. during a patient scan, the hps headphones had become warm and hence, uncomfortable for the patient to wear. subsequent investigation of the affected product showed clear indications of overheating. neither the patient nor the operator were injured. however, the headphone was sufficiently heated to potentially cause injury.
  • 조치
    Siemens is advising users to immediately stop using the affected headphones until further notification. Users are to use the standard auditory system from the scanner vendor (pneumatic) until resolution of the matter. Users who require high audio quality are requested to contact Siemens customer service for information on the possibility to receive a set of NNL Ear Plugs as a temporary solution until the matter is resolved.

Device

Nordic Neuro Lab Headphones used with Siemens MRI systems
  • 모델명 / 제조번호(시리얼번호)
    Nordic Neuro Lab Headphones used with Siemens MRI systemsHeadphones (HP)Catalogue Numbers: HP-1.3-20169-685 to HP-1.3-2016-693 Serial Numbers: 150694 to 150701Headphones Slim (HPS)Catalogue Numbers: HPS-1.0-2015-001 to HPS-1.0-2016-051Serial Numbers: 160052 to 160074ARTG Number: 186703
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd