Events

Device Recall Voluson Pro/Expert 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 General Electric Med. Sys. Ultrasound 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
    35066
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1172-06
  • 사례 시작날짜
    2006-02-24
  • 사례 출판 날짜
    2006-06-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-01-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45212
  • 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, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
  • 원인
    In the cardiac measurement section of the device the calculation of the 'pg mean' (mean pressure gradient) leads to an erroneous result. it is recommended that customers with affected units do not use the measurement in question 'pg mean' for any diagnostic or therapeutic decision, and 'pg mean' values should not be included in any patient documentation.
  • 조치
    An Urgent Medical Device Correction letter to customers 04/17/2006, states the product affected, provides a recommendation for affected units continued use until a software update is provided to the facility by a GE Healthcare Representative. Customers are recommended to not use the measurement in question 'PG Mean' for any diagnostic or therapeutic decision, and 'PG mean' values should not be included in any patient documentation.

Device

Device Recall Voluson Pro/Expert
  • 모델명 / 제조번호(시리얼번호)
    Software versions 4.0.0, 4.0.1, 4.0.2, 4.0.3, 4.0.4, 4.0.5, 5.00, 5.0.1. Serial number ranges A06251 thru A09914, A12012 thru A31198 and A35001 thru 35097 may include devices that are not subject to the correction.  Serial number ranges A10000 thru A11087 and A31201 thru A33742 only include devices subject to the correction
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide, Puerto Rico and OUS to include: Algeria, Argentina, Austria, Belgium, Bosnia and Herzegovina, Brazil, Republic of Bulgaria, Byelorussian SSR, Canada, China, Croatia, Cyprus, Czech Republic, Denmark, DVU Australia, Ecuador, Egypt, Finland, France, Federal Republic of Germany, Greece, Hong Kong, Republic of Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Kuwait, Republic of Lithuania, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Paraguay, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Kingdom of Saudi Arabia, Singapore, Republic of Slovenia, Spain, Sudan, Sweden, Switzerland, Taiwan, United Republic of Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Venezuela, Vietnam, Yemen, Yugoslavia
  • 제품 설명
    Voluson 730 Expert, Voluson 730 Pro, Voluson 730 ProV with software versions 4.0.0, 4.0.1, 4.0.2, 4.0.3, 4.0.4, 4.0.5, 5.00, 5.0.1. The device is a general-purpose diagnostic ultrasound system.
  • Manufacturer
    General Electric Med. Sys. Ultrasound

Manufacturer

General Electric Med. Sys. Ultrasound
  • 제조사 주소
    General Electric Med. Sys. Ultrasound, 4855 W Electric Ave, West Milwaukee WI 53219-1628
  • Source
    USFDA