Events

Device Recall Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fu 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
    64678
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1097-2013
  • 사례 시작날짜
    2013-01-15
  • 사례 출판 날짜
    2013-04-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-04-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116754
  • 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
    Siemens has become aware of a potential malfunction and possible hazard to patients and staff when using the iconos r200 c20, iconos r200 t20, iconos r100, iconos md, iconos rhd, luminos rf classic, luminos fusion or luminos select. this malfunction is possible in cases where the table vertical lift movement is obstructed by a solid object which could potentially result in collision. this can re.
  • 조치
    Siemens sent a Customer Safety Advisory letter dated January 15th, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The SIEMENS service representative will investigate if parts need to be exchanged in your product, an if so, which parts need to be exchanged to restore the system safety and function. Please kindly confirm receipt of the Field Safety Notice by sending back the attached form. For further questions please call (610) 448-3237.

Device

Device Recall Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF C...
  • 모델명 / 제조번호(시리얼번호)
    Model Number 5902767 with serial numbers 2217, 2038, 1228, 1007, 1219, 2156, 2264, 2190, 2132, 2213, 1484, 2166, 2259, 2068, 1610, 1601, 1413, 2236, 2153, 1444, 1477, 1632, 2037, 2180, 1663, and 1612; Model Number 5902783 with serial numbers 1003, 1401, 1402, and 1405; Model Number 7152478 with serial numbers 2580, 2524, 2590, 2536, 2563, and 2534; Model Number 10093962 with serial numbers 5837, 5120, 5523, 5910, 5507, 6141, 4112, 6274, 4506, 5900, 4121, 6245, 6242, 4509, and 6113.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including the states of CA, FL, GA, IA, IN, KS, LA, ME, MI, MO, NC, NH, NJ, NY, NV, OH, PA, TN, TX, VA and WA.
  • 제품 설명
    Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select. || Angiographic x-ray system.
  • 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