Events

Device Recall RadrexI DRAD3000E; 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
    52816
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1177-2010
  • 사례 시작날짜
    2009-05-22
  • 사례 출판 날짜
    2010-03-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-03-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84063
  • 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
    Solid State X-Ray Imager - Product Code MQB
  • 원인
    Toshiba america medical systems inc (tams) has initiated a field correction on the drad-3000e; radrex-i, electrostatic x-ray imaging system due to a software bug that results in a loss of image.
  • 조치
    An Urgent - Medical Device Correction letter was sent to customers. The letter described the issue, the corrective action, and the avoidance. Toshiba America Medical Systems informed customers that software was being prepared to address the issue and planned to send representatives to each customer affected by the field correction to provide a software upgrade to the DRAD-3000E; Radrex-I, Electrostatic x-ray imaging system. Customers were to complete the attached customer reply form. Questions were to be directed to Aaron Ybarra, X-ray Product Manager at 800-421-1968, ext. 2492.

Device

Device Recall RadrexI DRAD3000E;
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: U2A0872007, U2A08Y2012, U2A08Z2014, U2A0892009, U2A08Z2013, U2A0912016, U2A08X2010, U2A08X2011, U2A0862006, U2A0832002, U2B0852005, U2A0832001, U2B0842003, U2A0942019, U2A0942020, U2A0942021, U2A0942017, and  U2A0882008.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution -- Including states of PA, VA, OH, TN, LA, IL, CA, MT, AZ, and TX.
  • 제품 설명
    Toshiba America Medical Systems Inc (TAMS) Digital Radiography System Radrex-i DRAD-3000E; Electrostatic x-ray imaging system
  • 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