Events

Device Recall Coherence Therapist system 2.1 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
    46200
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0972-2008
  • 사례 시작날짜
    2007-10-02
  • 사례 출판 날짜
    2008-04-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-12-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66977
  • 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
    Linear Medical Accelerator - Product Code IYE
  • 원인
    Image orientation incorrect (image shifts) - 1) if the reference image has been calibrated for centering and the reference image is used for patient positioning, the image will shift when the positioning tools are used. 2) this problem occurs only when non-square reference images are used, such as when images are cropped. at this point, the images will refresh, and the center of the reference im.
  • 조치
    On 10/03/2007, the firm sent Consignees a Customer Safety Advisory Notice informing them of the two potential issues with the display of reference images used for position correction. Consignees will be informed when a solution to this issue has been validated.

Device

Device Recall Coherence Therapist system 2.1
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 10007, 10010, 10015, 10017, 10020, 10026, 10028, 10030, 10037, 10038, 10001, 10003, 10004, 10005, 10008, 10009, 10011, 10019, 10027, 10031, 10039, 11004, 11006, 10006, 10018 ,10021, 10022, 10024, 10025, 11005, 10016, 10023, 10029, 10032, 10033, 10035, 10036, 10040, 11001, and 11008.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA including 48 consignees in the US and 39 outside the US.
  • 제품 설명
    Siemens Coherence Therapist system, Part No: 7339125, medical charged-particle radiation therapy system with software version 2.1. Siemens AG, Concord, CA.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • 제조사 주소
    Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord CA 94520-1200
  • Source
    USFDA