Events

AXIOM Luminos dRFsystem 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
    68110
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1711-2014
  • 사례 시작날짜
    2014-04-11
  • 사례 출판 날짜
    2014-06-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-12-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126953
  • 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
    It was determined that under rare environmental conditions (i.E., extremely dry air in combination with a highly isolated floor) electrostatic discharges (esd) >8 kv may trigger an unintended movement of the axiom luminos drfsystem which may lead to an emergency situation and pose danger to the patients, operating personnel or to the unit.
  • 조치
    Siemens sent an Safety Advisory Notice dated April 11, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. What steps can the user take to avoid the potential risk of this issue? Press one of the red emergency STOP buttons immediately in case of an unintended movement. The system needs to be restarted afterwards to be fully functional again. How will the issue finally be resolved? Siemens is preparing a modification of the Luminos dRF system control console that will resolve this potential malfunction. The field modification will be available by end of May 2014. We appreciate your understanding and cooperation with this safety advisory notice and ask you to immediately instruct your personnel accordingly. Please ensure that this safety advisory notice is placed in the system's instructions for use until the update has been installed. If you have sold this device/equipment and it is no longer in your possession, we kindly ask that you forward this safety notice to the new owner of this device/equipment. Please inform us about the new owner of the device/equipment. For further questions please call (610) 219-6300.

Device

AXIOM Luminos dRFsystem
  • 모델명 / 제조번호(시리얼번호)
    Model number: 10094200, serial numbers:4332 4291 4323 4430 3061 4331 4238 4297 4201 4024 3098 4252 4372 4354 4077 3050 3108 4327 4342 4251 3053 3114 4156 3145 3096 4043 3181 4208 3090 4143 4051 4199 4401 4405 4151 4373 4276
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Class II Recall - US Distribution including the states of IL,VA, TN, PA, TX, MN, GA, MI, IN, OH, FL, CA, OR, NY, ME, MO, OK, CO and NJ.
  • 제품 설명
    AXIOM Luminos dRFsystem || The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.
  • 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
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA