Events

Device Recall LANTIS software 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
    34166
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0364-06
  • 사례 시작날짜
    2005-01-06
  • 사례 출판 날짜
    2006-01-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-05-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43217
  • 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
    Accelerator, Linear, Medical - Product Code IYE
  • 원인
    When using the creatine clearance dose calculations a software bug will allow the algorithm to assume a patients age to be in years when it is entered in months. this miscalculation may result in patients less than two years old to be seriously overdosed with radiation.
  • 조치
    The firm has sent out notification letters to the 18 sites with the activated MedOnc option. All 18 site had the letters delivered by Siemens Medical Solutions field service personnel by 1/6/2005.

Device

Device Recall LANTIS software
  • 모델명 / 제조번호(시리얼번호)
    Serial #: 93-0001, 93-0016, 93-0027, 93-0289, 93-0304, 93-0306, 93-0333, 93-0368, 93-0430, 93-0436, 93-0549, 93-0639, 93-0641, 93-0652, 93-0664, 93-0703, 93-0718 and  93-0786
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    A total of 18 sites were identified by the firm as having the MedOnc module activated; 6 within the United States U.S.) and 12 outside of the U.S.
  • 제품 설명
    LANTIS software with MedOnc Module; || MedOnc module is an option of the LANTIS radiotherapy treatment planning software distributed as a component of the firm''s linear accelerator used to deliver radiation therapy to cancer patients. || The MedOnc module is distributed by Siemens Medical Solutions USA ¿ Oncology Division, 4040 Nelson Avenue, Concord, CA 94520 with their linear accelerators software package called LANTIS. The MedOnc module option is distributed with all LANTIS software copies, but the module must be turned on by an electronic key that is purchased by individual hospitals. || Siemens Medical Solutions USA purchases the LANTIS software (code) from IMPAC Medical Systems, Inc., 100 West Evelyn Avenue, Mountain View, CA 94041 (REG#2950347, FEI: 1000123805). IMPAC distributes the same software under the name SEQUENCER.
  • 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