Events

Device Recall Taylor Spatial Frame Website software 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Smith & Nephew, 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
    78840
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0409-2018
  • 사례 시작날짜
    2017-12-13
  • 사례 출판 날짜
    2018-01-08
  • 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=160710
  • 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
    Software for diagnosis/treatment - Product Code OSN
  • 원인
    In rare circumstances, when surgeons use the software to plan the strut adjustment, an inverted image of the frame is generated by the software. the frame will appear inverted in the preview images on the strut settings tab.
  • 조치
    The firm initiated their recall by email on 12/13/2017. Users are asked if they notice an inverted frame in the software to repeat the process for the same case and notify a Smith & Nephew representative. In addition, they are asked to double check plannings for strut adjustments and compare with the images printed as described above.

Device

Device Recall Taylor Spatial Frame Website software
  • 모델명 / 제조번호(시리얼번호)
    Version 5.2.5 and 5.2.6
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide
  • 제품 설명
    Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401. A web-based and mobile application software component of a multilateral external fixation system that is intended for fracture fixation, fixation of long bones and for joint fusions and limb lengthening or deformity corrections which involve cutting of the bone.
  • Manufacturer
    Smith & Nephew, Inc.

Manufacturer

Smith & Nephew, Inc.
  • 제조사 주소
    Smith & Nephew, Inc., 1450 E Brooks Rd, Memphis TN 38116-1804
  • 제조사 모회사 (2017)
    Smith & Nephew plc
  • Source
    USFDA