Events

Device Recall Gemini 16, GS, GXL, Precedence. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems (Cleveland) 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
    37567
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0013-2007
  • 사례 시작날짜
    2006-11-06
  • 사례 출판 날짜
    2007-09-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-10-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50795
  • 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
    PET/CT computed tomography system - Product Code KPS
  • 원인
    A potential anomaly was identified on the ct subsytem, which could result in the radiation dose being different than the calculated dose reported to the operator.
  • 조치
    The customers were sent Public Safety Notification November 3, 2006, indicating there was a problem with the software. However, since their unit was recently upgraded the problem did not impact their unit.

Device

Device Recall Gemini 16, GS, GXL, Precedence.
  • 모델명 / 제조번호(시리얼번호)
    Serial #s:  4034-4100, 4102, 4103, 1041
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide, including USA, Australia, Canada, China, England, Finland, France, Germany, Ireland, Israel, Italy, Japan, Jordan, Korea, Netherlands, Poland, Puerto Rico, Spain, and Taiwan.
  • 제품 설명
    Nuclear medicine systems: || Gemini 16, Model 4535 679 28961. || Gemini GXL, Models # 4535 679 71891, #4535 679 75681, #4535 679 75691. || Precedence, Model #2169 -3000A, #2169-3001A, #2169-3002A, and 2169-3003A. || PET/CT Computed tomography systems.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • 제조사 주소
    Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
  • Source
    USFDA