Events

Device Recall Aquilion One: Aquilion TSX301B 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
    58031
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2896-2011
  • 사례 시작날짜
    2011-01-07
  • 사례 출판 날짜
    2011-07-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98287
  • 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
    X-ray Tomography System - Product Code JAK
  • 원인
    Toshiba america medical systems (tams) is initiating a field correction for the tsx-301a and tsx-301b: aquilion 64 system, x-ray, tomography because communication between reconstruction units in the system console may be broken due to failure of the optical conversion connector, resulting in a break of communication between units.
  • 조치
    Toshiba America Medical Systems, Inc. sent an "Urgent Medical Device Correction" letter dated January 4, 2011 to all affected customers. The letter provides the customers with an explanation of the problem and the firms plan to install preventive measures and provided them with a Customer Reply form to send Toshiba. A representative will contact the customers for an appointment to install the measures to their CT system. For question on this recall call (800) 421-1968 or contact your local Toshiba Representative at (800) 521-1968.

Device

Device Recall Aquilion One: Aquilion TSX301B
  • 모델명 / 제조번호(시리얼번호)
    1DA1062015, 1DB1072016, 1DB1082017, 1DB1082018, 1DB1082019
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    (USA) Nationwide Distribution including the states of WI, MO, TN, IA, AL, AZ, TX, and GA.
  • 제품 설명
    Aquilion One: Aquilion TSX-301B, 64 System, X-Ray, Tomography. || Toshiba American Medical Systems, Inc. || A multislice CT system that 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 92781-2068
  • 제조사 모회사 (2017)
    Canon Inc
  • Source
    USFDA