Events

Device Recall TSX30IC: AQUlLlON ONE; System, XRay, Tomography, Computed. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Toshiba American Medical Systems 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
    64673
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1068-2013
  • 사례 시작날짜
    2012-11-14
  • 사례 출판 날짜
    2013-04-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-04-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116744
  • 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
    Due to a problem with the control software of the x-ray high-voltage generator, if scanning is performed with a tube current less than 30ma, the control software may detect an error and perform error processing even though the x-ray output is normal.
  • 조치
    Toshiba American Medical Systems Inc. sent a Urgent Medical Device Correction letter dated November 14, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customer was informed a New software to prevent the occurrence of this issue will be installed on your system. Toshiba Service Representative will contact you for an appointment to install the New Software on your Aquilion One System. Please fax the return reply form to (877) 349-3054. We thank you for your urgent attention to this matter. If you have any further questions regarding this letter please call (800) 521-1968.

Device

Device Recall TSX30IC: AQUlLlON ONE; System, XRay, Tomography, Computed.
  • 모델명 / 제조번호(시리얼번호)
    Serial No: 1CB1262006
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed in the state of MD.
  • 제품 설명
    Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.
  • Manufacturer
    Toshiba American Medical Systems Inc

Manufacturer

Toshiba American Medical Systems Inc
  • 제조사 주소
    Toshiba American Medical Systems Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92780-7047
  • 제조사 모회사 (2017)
    Canon Inc
  • Source
    USFDA