Events

Device Recall Artis one 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
    79538
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1148-2018
  • 사례 시작날짜
    2018-01-12
  • 사례 출판 날짜
    2018-03-20
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162604
  • 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
    Certain patient table systems may have a missing or incorrectly installed snap ring that could cause the bolt to slide out of its base and the tabletop carriage to slide to the floor.
  • 조치
    Siemens sent an Urgent - Medical Device Correction letter dated January 5, 2018. Siemens will conduct an inspection of all affected Artis tables and verify the correct positioning of the bolt as well as the snap rings. The letter recommends the consignees follow Please follow the standard emergency procedures they have in place in the event of system failures. It is recommended to consider reinforcing these emergency procedures until the update has been completed. The Siemens service organization will contact the consignees to arrange a date to perform the corrective action. For further questions, please call (610) 448-6461.

Device

Device Recall Artis one
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: 82044 82105 82070 82213 82054 82040 82038 82205 82065 82267 82108 82010 82039 82109 82102 82066
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to the states of : AL, AR, CA, FL, IN, LA, MI, MO, NC, NY, PA, TX, and WA.
  • 제품 설명
    Artis one fluoroscopic x-ray system and patient table || Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Arts one include cardiac angiography, neuro-angiography, general angiography, rotational angiography; multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • 제조사 주소
    Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Malvern PA 19355-1418
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA