ALLURA XPER FD10/10 - MAIN UNIT 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 PHILIPS ELECTRONICS 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
    143084
  • 사례 위험등급
    II
  • 사례 시작날짜
    2017-12-28
  • 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
    Philips has become aware that extra monitors so called 7th or 8th monitor mounted on the monitor ceiling suspension (mcs) might disengage from the mcs and fall down. the two small set screws securing the two gliding rods into an aluminum block of the support arm can come loose because of vibrations and forces exerted on them. if the set screws have come loose gravity can keep the rods in position. however if a force is exerted on the monitor pushing it forward the monitor can topple forward. once the monitor has toppled over it is only attached with its wires. if the monitor breaks loose of its wires it will drop on the floor. see e-file for french translation.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: ALLURA XPER FD10/10 (Lot serial: N/A); Model Catalog: ALLURA XPER FD20/10 (Lot serial: N/A); Model Catalog: ALLURA XPER FD20/20 (Lot serial: N/A); Model Catalog: ALLURA XPER FD10 (Lot serial: N/A); Model Catalog: ALLURA XPER FD20 (Lot serial: N/A); Model Catalog: 000454 (Lot serial: N/A)
  • 제품 설명
    ALLURA XPER FD10/10 - MAIN UNIT;ALLURA XPER FD20/10 SYSTEM-MAIN UNIT;ALLURA XPER FD20/20;ALLURA XPER FD10;ALLURA XPER FD20 SYSTEM - MAIN UNIT;ALLURA XPER FD20 OR TABLE
  • Manufacturer

Manufacturer

  • 제조사 주소
    MARKHAM
  • 제조사 모회사 (2017)
  • Source
    HC