Events

Device Recall XARIO 100 TUSX100 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
    77599
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2708-2017
  • 사례 시작날짜
    2017-05-01
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156746
  • 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, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • 원인
    When continuous trace method is used as the tracing method on spectral doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below.
  • 조치
    Toshiba Medical sent an Urgent Medical Device Correction letter on May 1, 2017. The consignee is instructed not to use the Continuous Trace method for cardiac velocity trace measurements to quantify the MPG values. Modified software is being provided. A Toshiba service representative will contact the consignee to make an appointment to install the modified software to fix the problem. Customers were asked to complete the form and fax it to the toll-free number shown at the top of the form. The form can also be sent by email to RAffairs@tams.com. Customers with questions were instructed to call 800-521-1968.

Device

Device Recall XARIO 100 TUSX100
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: W5B16Z2555, W5B1712642, MXA1723100, MXA1723098, MXA1723101, MXA1723099, MXA1723097
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    XARIO 100 TUS-X100 || diagnostic ultrasound system
  • Manufacturer
    Toshiba American Medical Systems Inc

Manufacturer

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