Device Recall GE Healthcare, Seno Advantage 2.1 and 2.2 Workstations 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
    59059
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3012-2011
  • 사례 시작날짜
    2011-05-31
  • 사례 출판 날짜
    2011-08-12
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-06-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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 become aware that patient mismatch could occur on some seno advantage 2.1 and 2.2 workstations with ris ccow integration. this issue may impact patient safety. when seno advantage workstation is synchronized with ris using ccow (an hl7 standard protocol designed to enable disparate applications to synchronize in real-time), the following issues could occur: 1. two different.
  • 조치
    GE Healthcare sent a URGENT MEDICAL DEVICE CORRECTION letter to all affected customers dated May 31, 2011. The letter identified the product , the problem and the action needed to be taken by the customer. GE Healthcare will upgrade all affected workstations at no cost. A GE Healthcare service representative will contact you 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

  • 모델명 / 제조번호(시리얼번호)
    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0U7164001 000000U7164003 000000U7164004 000000T7323004 000000C7177015 000000C7177008 000000C7177009 000000C7177010 000000Q7274005 000000K7291002 000000U9077001 000000R9131003 000000R9131004 00000Q11031001 00000Q11031003 000000ANT23045 000000ANT23046 000000ANT23047 000000ANT25611 000000N7302001 00000F10243002 00000F10243003 00000L10092001 00000M10223002 00000M10223003 000000G9278003 000000G9278004 000000G9278005 000000N7302002 000000S8206001 000000P9314001 000000U7164005 000000C7177002 000000G8021001 000000W8297001 000000ANT26269 000000G8087001 000000G8087002 000000ANT25613 000000ANT23044 000000C7177007 00000106420GE3 00000142840GE8 00000168707GE8 00000170713GE2 00000220619GE1 00000218672GE4 00000220620GE9 00000L10151001 00000K10032001 000000D8247001 000000T9021002 000000U9077002 000000R9131002 00000Y10214003 00000050606AW3 000000N7302003 000000W9301002
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--USA (nationwide) including the states of: AZ, CA, CO, CT, FL, GA, HI, IL, IN, IA, LA, MD, MA, MI, MN, MO, MT, NE, NJ, NY, NC, OK, OR, PA, SC, TN,TX, and WI, and the countries of UNITED KINGDOM, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, PORTUGAL NORWAY, NEW ZEALAND, LUXEMBOURG, LEBANON, KOREA, JAPAN, ITALY, IRELAND, GERMANY, FRANCE, DENMARK, CANADA, BELGIUM AUSTRIA, AUSTRALIA FINLAND.
  • 제품 설명
    GE Healthcare, Seno Advantage 2.1 and 2.2 Workstations with RIS CCOW integration, GE Healthcare 3000 North Grandview, Waukesha, WI 53188 || 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

Manufacturer

  • 제조사 주소
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
  • Source
    USFDA