Events

Device Recall Siemens Artis Q/Q.zen 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
    76016
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0972-2017
  • 사례 시작날짜
    2016-12-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151943
  • 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
    Siemens initiated a corrective action to address two possible, mutually independent causes of a system defect related to the following: - in artis systems with a100 plus or a100g generators, an attempt to resume operation following detection of a fault can result in the failure of a module in the high-voltage generator. - for biplane systems delivered with software version vd11b since april of this year, software problems in conjunction with graphics card may, in rare cases, result in the loss of image display in the examination room.
  • 조치
    Siemens mailed a Customer Safety Advisory Notice (CSAN) dated December 8, 2016, to all affected customers with Customer Safety Advisory Notice AX002/16/S. Additionally, Siemens has initiated a software update via Update Instruction AX001/16/S. Their Service Organization will contact each customer to schedule an appointment to perform the corrective action; however, customers can make contact for an earlier appointment. Customers with questions should call 1-888-826-9702. For questions regarding this recall call 610-448-6461.

Device

Device Recall Siemens Artis Q/Q.zen
  • 모델명 / 제조번호(시리얼번호)
    Model # 10848280, 10848281, 10848282, 10848353, 10848354, 10848355
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Artis Q/Q.zen, Angiographic x-ray system || Stand alone system || The Artis systems are 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. Procedures that can be performed with the Artis zee/ zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee/ zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis
  • 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