Events

Device Recall GE QUASAR NUCLEAR MEDICINE SYSTEM 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Medical Systems, 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
    50927
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1120-2009
  • 사례 시작날짜
    2008-06-02
  • 사례 출판 날짜
    2009-04-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77820
  • 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
    The metal pin in the adjustable head holder, which is used to acquire brain spect data on infinia systems (infinia, infinia hawkeye¿, and infinia hawkeye¿ 4), creates an artifact on the patient's cerebellum, which may lead to the potential for misdiagnosis.
  • 조치
    Consignees were sent a GE "Product Safety Notification" letter dated April 2008. The letter was addressed to Hospital Administrators, and Managers of Radiology/Cardiology, Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product, Safety Instructions, Product Correction and Contact Information. Contact your local sales or service representative for further information regarding this notification by calling 1-800-437-1171 (within the US or Canada) and 1-262-896-2890 (outside the US).

Device

Device Recall GE QUASAR NUCLEAR MEDICINE SYSTEM
  • 모델명 / 제조번호(시리얼번호)
    Model Number H3000WR: 16306 and 16275;   Model Number H3000WW: 16086 16202 16231 16241 16268 16265 16247 16277 16201 16272 16274 16258 16278 16242 16257 16341 16307 16232 16351 16358 16363 16383 16134 16383 16367 16095 16359 16338 16338 16390 16407 16253 16463 16242 16461 16484 16467 16472 16486 16393 16488 16507 16545 16459 16546 16523 16550 16521 16402 16417 16599 16556 16480 16558 16597 16555 16590 16603 16598 16606 16618 16630 16596 16530 16619 16609 16631 16623 16691 16708 16620 16633 16642 16599 16703 16591 16671 16764 16757 16604 16787 16615 16287 16690 16568 16458 16711 16727 16386 16729 16444 16260 16678 16687 16588 16700 16653 16730 16782 16824 16342 16879 16003 16801 16884 16292 16906 16892 16931 16952 16954 16954 16222 16936 16895 16257 16951 16373 16958 16389 16982 16981 17038 16754 16985 16998 16855 16458 16644 and 16544;   Model Number H3000WZ: 16237 16350 16251 16375 16387 16512 16565 16582 16403 16240 16183 16572 16485 16552 16248 16215 16261 16197 16468 16361 16624 16813 16409 16831 16481 16240 16264 16891 16961 16826 and 17148;   Model Number H3000YM: 16046 16011 16021 16057 16027 16128 16077 16097 16019 16103 16082 16112 16029 16121 16157 16148 16159 16038 16147 16146 16127 16154 16174 16024 16024 and 16133; and   Model Number H3000YS: 16068 16089 16141 16085 and 16061.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (DC and Puerto Rico) including states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, and WI and countries of Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech, Denmark, Ecuador, Egypt, Finland, Finland, Egypt, Finland, France, Germany, Greece, Hungry, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Malaysia, Martinique, Mexico, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Republic of Georgia, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, and United Kingdom.
  • 제품 설명
    GE Healthcare, Hawkeye¿ for Infinia, Model Numbers: H3000WR , H3000WW, H3000WZ , H3000YM and H3000YS. || The device is used to perform 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 optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

GE Medical Systems, LLC
  • 제조사 주소
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    USFDA