Events

Device Recall Seno Advantage 2.2 workstations with software version 22_01 and 22_02 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ge Healthcare, Llc 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
    55387
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1747-2010
  • 사례 시작날짜
    2010-02-09
  • 사례 출판 날짜
    2010-06-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-12-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90741
  • 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, image processing, radiological - Product Code LLZ
  • 원인
    Ge healthcare has recently become aware of inaccurate scale factor annotation provided by senoadvantage 2.2 workstations that may impact patient safety. when using the print image or print screen feature on senoadvantage 2.2, the scale factor annotation printed on hard copy images is inaccurate. secondary capture (scpt) images displayed on the screen and secondary capture hard copy images may a.
  • 조치
    The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter dated February 8, 2010 to customers. The letter described the Safety Issue, Affected product details, Safety Instructions to prevent further inaccurate scale factor annotation, Product Correction and Contact Information. GE Healthcare will correct all affected workstations by providing a software upgrade and an updated Operator Manual. The GE service representative will contact customer to arrange for this correction. If you have any questions or concerns regarding this notification, please call one of the following phone numbers: United States: 800-437-1171, Japan: -0120-055-919. For other countries, please contact your local GE Healthcare Service Representative.

Device

Device Recall Seno Advantage 2.2 workstations with software version 22_01 and 22_02
  • 모델명 / 제조번호(시리얼번호)
    SERIAL NUMBER 000000A9316002 000000A9316008 000000F9314002 000000F9314013 000000Q9309007 000000Q9309012 000000Q9309013 000000Q9309015 000000W9321002 000000W9321004 000000A9316004 000000A9316014 000000A9316015 000000A9345002 000000A9345003 000000A9345007 000000A9345009 000000A9345019 000000A9345020 000000F9314005 000000F9314010 000000F9314014 000000Q9309002 000000Q9309003 000000Q9309006 000000W9321003 000000P9300003 000000A9316012 000000P9300002 000000F9314011 000000W9321001 000000W9321007 000000W9321008 000000W9321010 000000W9321006 000000A9316006 000000A9316003 000000A9316005 000000P9300001 000000Q9309010 000000Q9309014 000000A9345015 000000Q9309005 000000A9316011 000000A9345012 000000A9345013 000000A9345014 000000A9345016 000000A9345018 000000F9314004 000000Q9309001 00000D10011003 00000D10011006 000000A9316001 000000F9314008 000000F9314012 000000P9300004 000000W9321009 000000A9316010 000000F9314007 000000W9321005 000000A9316007 000000A9316009 000000F9314015 000000F9314006 000000Q9356005 00000ZA9260001 000000Q9309008 000000A9345001 000000A9345017 000000F9314001 000000Q9309004 000000Q9356001
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including states of CA, FL, GA, MD, NJ, NM, NY, NC, OK, TX and countries of THAILAND, TAIWAN, SWEDEN SPAIN, SAUDI ARABIA, RUSSIAN FEDERATION, PORTUGAL, PAKISTAN, MEXICO, JAPAN, ITALY,GREECE, FRANCE, COLOMBIA, CHILE, CANADA, BELGIUM, and BAHRAIN.
  • 제품 설명
    GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 || Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, mammographic images displayed on the high-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis.
  • Manufacturer
    Ge Healthcare, Llc

Manufacturer

Ge Healthcare, Llc
  • 제조사 주소
    Ge Healthcare, Llc, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    USFDA