DASH 4000 PATIENT MONITOR 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE) 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
    106164
  • 사례 위험등급
    III
  • 사례 시작날짜
    2013-01-18
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    Ge healthcare became aware of the following issues affecting dash 3000/4000/5000 patient monitors and dash port 2. dash 3000/4000/5000 patient monitors: 1. dash stops communicating on the unity network resulting in loss of monitoring at the carescapet cic pro central station* 2. dash displays distorted ecg waveforms in combination monitoring mode 3. dash incorrectly becomes time master on the unity network 4. dash date reverts to 1993 dash port 2: 5. dash port 2 stops communicating on the unity network resulting in loss of monitoring at the carescapet cic pro central station* *despite communication loss the dash 3000/4000/5000 will continue to provide bedside monitoring including alarms and event storage.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: DASH4-XXXX-XXXX-XXXX (Lot serial: > 10 lot numbers contact mfg); Model Catalog: DASH5-XXXX-XXXX-XXXX (Lot serial: >10 lot numbers contact mfg); Model Catalog: 2041850-002 (Lot serial: >10 lot numbers contact mfg); Model Catalog: DASH3-XXXX-XXXX-XXXX (Lot serial: > 10 lot numbers contact mfg)
  • 제품 설명
    DASH 4000 PATIENT MONITOR
  • Manufacturer

Manufacturer