Events

Siemens SOMATOM Go.Up 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
    80047
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1940-2018
  • 사례 시작날짜
    2018-04-20
  • 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=164276
  • 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, tomography, computed - Product Code JAK
  • 원인
    There is a potential for a software issue that may cause the need for necessary patient rescans.
  • 조치
    The firm, Siemens Healthineers, sent an "Customer Safety Advisory Notices" letter dated 4/20/2018 beginning on 4/20/18 to its customers. The letter described the product, problem and actions to be taken. The letters provided the following information to customers: How can the operator help to avoid a potential risk of the system? To avoid an unnecessary additional X-ray dose to patients please observe the following instructions: Topic 1: If a reconstruction cannot be started after an examination, please reboot the system and repeat the aborted reconstruction. If the error persists, please contact your local Siemens Healthineers service support team. They can help you to decide whether a rescan is necessary or not. Topic 2: If you change the scan parameters kV or mA (tube HV or current), please wait for at least 12 seconds before you trigger a scan command on the control box. If artifacts are visible in the topogram, please repeat the topogram before starting the volume scan. If you have started a volume scan and detect artifacts in the real time display, please stop the scan immediately to avoid an unnecessary X-ray dose. Topic 3: After an osteoporosis scan has been completed, the Osteo reconstruction needs to be started and completed directly after the scan. Therefore the images should be loaded and checked in CT View&Go; before the scan/recon tab card is closed. Please do not close the scan/recon tab card before you have reconstructed and checked all Osteo images. A successful and complete Osteo reconstruction is visualized by full green bars in the column Recon Progress of the Job Status table and by images including the Osteo phantom in the tab card CT View&Go; (for details please see Fig. 3 below). An example of a correct Osteo reconstruction is provided in Fig. 2. After checking the successful and complete Osteo reconstruction you may close the scan/recon tab card. What has been done to address these issues? What actions shall be t

Device

Siemens SOMATOM Go.Up
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 108052,  108053,  108054,  108055,  108056,  108057,  108058,  108059,  108060,  108061,  108062,  108063,  108064,  108065,  108066,  108067,  108068,  108069,  108070,  108071,  108072,  108073,  108074,  108075,  108076,  108077,  108078,  108079,  108080,  108081,  108082,  108083,  108084,  108085,  108086,  108087,  108088,  108089,  108090,  108091,  108092,  108093,  108094,  108095,  108096,  108097,  108098,  108099,  108100,  108101,  108102,  108103,  108104,  108105,  108106,  108107,  108108,  108109,  108110,  108111,  108112,  108113,  108114,  108115,  108116,  108117,  108118,  108119,  108120,  108121,  108122,  108123,  108124,  108125,  108126,  108127,  108128,  108129,  108130,  108131,  108132,  108133,  108134,  108135,  108136,  108137,  108138,  108139,  108140,  108141,  108142,  108143,  108145
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) including states of: AR, CA, CT, FL, GA, IL, IN, KS, KY, MO, ND, NY, OH, OK, SD, TN, TX, and VA; and countries of: Algeria, Australia, Austria, Bangladesh, Bolivia, Bosnia Herzog., Brazil, Cambodia, Chile, China, Columbia, Costa Rica, Germany, Greece, India, Indonesia, Italy, Japan, Kenya, Kuwait, Lithuania, Mauritius, Morocco, Nepal, Pakistan, Paraguay, Philippines, Poland, Portugal, Republic Korea, Romania, Senegal, Singapore, Slovakia, South Africa, Spain, Switzerland, Thailand, Turkey, Ukraine, and United Kingdom.
  • 제품 설명
    SOMATOM Go.Up, Material Number 11061628 || There is a potential for a software issue that may cause the need for necessary patient rescans.
  • 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