Events

Device Recall Aplio 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Toshiba American Med Sys 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
    37965
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0986-2007
  • 사례 시작날짜
    2007-02-02
  • 사례 출판 날짜
    2007-06-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-04-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52533
  • 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
    Ultrasound - Product Code IYN
  • 원인
    When using the lv measurement function and making numerous measurements the value displayed on the image screen may on occasion not update correctly. the values that are stored in mda (measurement display area) are correct and no issue has been reported with these values.
  • 조치
    Notification letters were sent to customers on February 2, 2007. Customers were informed of the safety issue regarding the possibility of incorrect measurement values being displayed on the active image screen while performing multiple measurements and instructed to verify actual results against the values stored in the MDA (measurement display area). Customers were also informed that a Toshiba Customer Service Engineer will contact them to schedule a software upgrade when software becomes available. If customers have any questions they were instructed to contact their Toshiba Customer Service Engineer or call (800) 421-1968 and ask for the Regulatory Affairs Department. Customers were also instructed to distribute this information to all users of the product and also with the Bio-medical Department at their facility.

Device

Device Recall Aplio
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers:  B2622263,  B2622264,  B2622265, B2622267, B2622269,  B3522364, B3522365, B3522366, B3522369, B3522370, B3522372, B3522373, B3522402, B3522403, B3522404, B3522405, B3552542, B3552557, B3552558, B3552560, B3562595, B3562599, B3582672, B3582673, B3582674, C3592771, C3592772, C3592773, C3592774, D4553251, D4553252, D4553253, D4563327, D4563329, E4593563, E4593564, F4603654, F4603655, F4603656, F4613730, F4613731, F4613732, F5513813, G5523871 & G5523875
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide
  • 제품 설명
    Toshiba Aplio 50 Digital Ultrasound System, SSA-700A with version 6 software
  • Manufacturer
    Toshiba American Med Sys Inc

Manufacturer

Toshiba American Med Sys Inc
  • 제조사 주소
    Toshiba American Med Sys Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92781-2068
  • Source
    USFDA