Events

Device Recall GE Healthcare Prodigy; Prodigy Advanced 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Medical Systems Ultrasound & Primary Care Diagnostics, LL 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
    79710
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1395-2018
  • 사례 시작날짜
    2018-03-16
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163129
  • 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
    Densitometer, bone - Product Code KGI
  • 원인
    Under certain conditions, when using dicom worklist along with dicom mpps, a report for a bone density exam may be sent to pacs with the incorrect patient information in the dicom header. the correct patient information will be listed on the dicom report image; however, the report may appear under a different patients name in the pacs.
  • 조치
    The firm initiated their recall by letter on March 16, 2018. The notice stated: "Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient information in the DICOM header. The correct patient information will be listed on the DICOM report image; however, the report may appear under a different patients name in the PACS. There have been no injuries reported as a result of this issue. You can continue using your system by disabling the DICOM MPPS feature as follows: 1. In enCORE, select Tools | Connectivity Options. 2. Select DICOM tab. 3. Press Configure Connections in DICOM Worklist section. 4. In the MPPS SCP Settings, clear the AE Title and the TCP/IP Address fields 5. Press OK to all. A GE Healthcare representative will contact you to arrange for the correction." For further questions, please call (608) 826-7492

Device

Device Recall GE Healthcare Prodigy; Prodigy Advanced
  • 모델명 / 제조번호(시리얼번호)
    a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626, LU40637, LU40626, LU40637, LU42021, LU42025, LU41730, LU41734, LU42344, LU42365  b) Prodigy Advanced, Model Numbers: LU42361, LU42397
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Lebanon, Malaysia, Malta, Mexico, Morocco, Norway, Poland, Portugal , Romania, Russia, Saudi Arabia, Spain, Switzerland, Taiwan, Tunisia, Turkey, United Arab, United Kingdom and Venezuela.
  • 제품 설명
    GE Healthcare: || a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626, LU40637, LU40626, LU40637, LU42021, LU42025, LU41730, LU41734, LU42344, LU42365 || b) Prodigy Advanced, Model Numbers: LU42361, LU42397 || Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be compared to a reference population at the sole discretion of the physician.
  • Manufacturer
    GE Medical Systems Ultrasound & Primary Care Diagnostics, LL

Manufacturer

GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
  • 제조사 주소
    GE Medical Systems Ultrasound & Primary Care Diagnostics, LL, 3030 Ohmeda Dr, Madison WI 53718-6704
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    USFDA