Events

Device Recall Artis Q, and Artis Q.zen ceiling systems 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Medical Solutions USA, Inc 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
    70016
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0972-2015
  • 사례 시작날짜
    2014-12-03
  • 사례 출판 날짜
    2015-01-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-04-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132115
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Interventional fluoroscopic x-ray system - Product Code OWB
  • 원인
    Suboptimal routing of the cable may result in increased wear over time. without additional measures, damage of a cable may result in limited functionality and in rare cases, failure of a system. an ongoing procedure could be terminated in rare cases.
  • 조치
    Siemens sent an important customer safety information notice, dated December 3, 2014, to all affected customers. The letter identified the product, problem, and action to be taken. The following hardware modifications will be implemented with the corrective action AX042/14/S: 1. A modified cable outlet to provide additional space for the cabling. 2. A modified plastic cover at the cable outlet providing optimal cable guidance in the area of the arc. In general all systems will be checked for existing damage prior to the implementation of this action. For questions regarding this recall call 610-219-6300.

Device

Device Recall Artis Q, and Artis Q.zen ceiling systems
  • 모델명 / 제조번호(시리얼번호)
    model numbers: 10848281; 10848354
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Artis Q, and Artis Q.zen ceiling systems; model numbers: 10848281; 10848354: The Artis family is dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • 제조사 주소
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355-1406
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA