Events

Device Recall AXIOM Artis 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
    79540
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1150-2018
  • 사례 시작날짜
    2018-01-05
  • 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=162606
  • 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
    System, x-ray, fluoroscopic, image-intensified - Product Code JAA
  • 원인
    Certain systems may have leaking of the plastic coolant couplings, the liquid can enter into the flat panel detector leading to a failure of the detector. it may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
  • 조치
    The firm, Siemens Healthineers, sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated 1/5/2018 to its consignees. The letter describes the product, problem and actions to be taken. The consignees were instructed to follow their standard emergency procedures in place in the event of system failures; to consider reinforcing these emergency procedures until the update has been completed. Siemens will replace all affected plastic couplings with metal couplings. The Siemens service organization will contact the consignees to arrange a date to perform this corrective action.If the device has been sold and is therefore no longer in your possession, please forward this field correction notice to the new owner. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436.

Device

Device Recall AXIOM Artis
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 35061 35054 34999 35098 35059 35064 35073 35071 35057 35075 35083 35018 35097 35108 35046 35048 35050 46004 35045 35004 44011 35095
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution in the following U.S. states: AZ, CA, FL, IA, IL, LA, MI, NC, NJ, OH, OK, and TX.
  • 제품 설명
    AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 || AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
  • 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