Events

Device Recall GE Discovery NM/CT 670 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
    60790
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1110-2012
  • 사례 시작날짜
    2012-01-11
  • 사례 출판 날짜
    2012-02-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-12-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106479
  • 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, tomography, computed, emission - Product Code KPS
  • 원인
    Ge healthcare has recently become aware of a potential safety issue associated with the collimator cart and lead cover of your discovery nm/ct 670 and/or discovery nm 630 system that may impact operator safety. 1. the cart locking pin release and cart disengagement could result in the collimator falling down and could lead to operator or service personnel injury. 2. another issue is that the.
  • 조치
    The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter dated January 13, 2012 to its Consignees/Customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The customers were instructed to continue to use product, ensure that the collimator exchange monitor the collimator cart are properly locked in place; pay attention to any unexpected cart motion during the exchange procedure; cease the process immediately if the cart has moved from the docking spot, dock cart in place again, and complete the exchange; and if a 3rd party service engineer is servicing rather than the firm, GE, advise according to the instructions in letter. A GE Healthcare Service representative will perform the required hardware update on each affected system. If you have any questions or concerns regarding this notification, contact your local GE Healthcare Service Representative. You may also contact GE Healthcare Call Center: United States or Canada: 800-437-1171 and Other countries: 262-896-2890.

Device

Device Recall GE Discovery NM/CT 670
  • 모델명 / 제조번호(시리얼번호)
    00ME1 21023 21030 21044 21045 21062 21065 21069 21077 21003 21006 21010 21027 21036 21043 21046 21051 21084 21005 21072 21007 21047 21011 21018 21025 21071 21026 21068 21038 21089 21012 21059 00P3 21031 21004 21014 21053 21024 21021 21022 21033 21035 21037 21063 21064 21067 21070 21073 21086 21009 21019 21055 21028 21052 21076 21083 21048 21061 21058 21001 21008 21034 21050 21056 21002 21013 21017 21020 21029 21039 21041 21066 21075 21079 21080 21081 21082 21016 21040
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) including states of: CA, FL, GA, IL, NJ, NY, NC, TX, and WI; and countries of: AUSTRALIA, BELGIUM, CANADA, CHINA, DENMARK, FRANCE, GERMANY, INDIA, ISRAEL, ITALY, KOREA, JAPAN, NETHERLANDS, NORWAY, POLAND, RUSSIAN FEDERATION, SPAIN, SWITZERLAND, UNITED KINGDOM.
  • 제품 설명
    GE Discovery NM/CT 670 || The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to produce: NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality.
  • 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