e.cam and Symbia E systems (Nuclear medicine gamma camera system) 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-2016-RN-01052-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2016-08-10
  • 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
    Siemens has received reports of patients’ hair being caught in the e.Cam and symbia e patient bed up/down drive. siemens is reminding users of the patient positioning instructions for the e.Cam or symbia e systems. additionally, an enhancement kit that reduces the gap in the patient bed up/down drive has been designed and will be installed by siemens.
  • 조치
    Siemens is reminding users of the positioning instructions for the e.cam and Symbia E systems that require operators to properly position the patient and observe the patient at all times. Siemens will be arranging for an enhancement kit to be installed by a Siemens service representative. This action has been closed-out on 23/06/2017.

Device

  • 모델명 / 제조번호(시리얼번호)
    e.cam and Symbia E systems (Nuclear medicine gamma camera system)Catalogue Numbers: 4380213, 4380221, 5242826, 5977066, 5977074, 5984005, 5989079, 5989087, 5989095, 5991109, 5991117, 5992099, 7324119, 7324135, 7324143, 7324150, 7760809, 7760932, 7761161, 7823920, 7823938, 7823946, 7823953, 7823961, 7823979, 10151531, 10151532, 10275879, 10413009, 10520745ARTG Numbers: 186317, 186317
  • Manufacturer

Manufacturer