Events

GE LightSpeed VCT 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
    56814
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0368-2011
  • 사례 시작날짜
    2010-09-03
  • 사례 출판 날짜
    2010-11-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94573
  • 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, x-ray, tomography, computed - Product Code JAK
  • 원인
    Ge has become aware of a potential set of circumstances that could cause x-ray continuation during an unexpected table stop on certain lightspeed vct and brightspeed systems.
  • 조치
    An Urgent Medical Device Correction letter dated September 2, 2010 was sent to consignees beginning September 3, 2010. This letter addressed the LightSpeed VCT systems. Another Urgent Medical Device Correction letter, dated September 24, 2010 was sent September 24, 2010 for the BrightSpeed Systems. The letters described the issue and provided safety instructions for the health care provider to be aware if the table should stop unexpectedly and the x-ray remains on to manually stop the scan until the devices software is upgraded. If you have any questions, please contact the US (800) 437-1171, Japan 0120-055-919, Korea 1544-6119, Australia/New Zealand 800 659 465, China 800-810-8188; for other countries, please contact your local GE Healthcare Services Representative.

Device

GE LightSpeed VCT
  • 모델명 / 제조번호(시리얼번호)
    Model 5212920-300, serial numbers: 00000021775YC2. 00000408285CN5. 00000409136CN9. 00000412029CN1. 00000412391CN5. 00000414803CN7. 00000415599CN0. 00000416813CN4. 00000417885CN1.   Model 5212920-310, serial numbers: 00000416740CN9. 00000417311CN8. 00000417519CN6. 00000417884CN4. 00000417886CN9. 00000417916CN4. 00000417917CN2. 00000417918CN0. 00000417919CN8. 00000417925CN5. 00000417926CN3. 00000417989CN1. 00000417990CN9. 00000418000CN6. 00000418055CN0. 00000418056CN8. 00000418057CN6. 00000418058CN4. 00000418059CN2. 00000418060CN0. 00000418062CN6. 00000418063CN4. 00000418064CN2. 00000418065CN9. 00000418126CN9. 00000418141CN8. 00000418142CN6. 00000418179CN8. 00000418218CN4. 00000418219CN2. 00000418220CN0. 00000418221CN8. 00000418222CN6. 00000418246CN5. 00000418260CN6. 00000418261CN4. 00000418266CN3. 00000418272CN1. 00000418293CN7. 00000418296CN0. 00000418337CN2. 00000418355CN4. 00000418365CN3. 00000418400CN8. 00000418404CN0. 00000418467CN7. 00000418541CN9. 00000418542CN7. 00000418581CN5. 00000418586CN4. 00000418604CN5. 00000418706CN8. 00000418717CN5. 00000418789CN4. 00000418790CN2. 00000418793CN6.   Model 5311595-10, serial numbers: 00000031546CO5. 00000031835CO2. 00000031838CO6.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including states of: MI, NM, OH, TX, and Puerto Rico and countries including: Algeria, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Honduras, Hungary, India, Indonesia, Ireland, Islamic Republic of Iran, Israel, Italy, Jamaica, Japan, Kenya, Lebanon, Malaysia, Mauritania, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Pakistan, Paraguay, Philippines, Poland, Portugal, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Togo, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Viet Nam.
  • 제품 설명
    GE LightSpeed VCT Scanner System, models 5212920-300, 5212920-310, 5311595-10. Composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image acquisition and reconstruction software, associated accessories and connections/interfaces to accessories. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188 USA. || Is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions.
  • 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