Events

Device Recall GE SIGNA Pioneer 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
    73555
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1347-2016
  • 사례 시작날짜
    2016-03-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-08-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144455
  • 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, nuclear magnetic resonance imaging - Product Code LNH
  • 원인
    Ferrous material in the signa pioneer table control box (tcb) could cause unexpected attraction to the mr system's high strength magnetic field during servicing activities. this could create a potential risk of serious injury to service personnel who attempt to inappropriately remove the tcb from the magnetic field. there have been no events reported as a result of this issue. clinical scanni.
  • 조치
    Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 68002 dated March 1, 2016. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers, and Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions or concerns regarding this notification,contact GE Healthcare Service at 18004371171 or your local Service Representative.

Device

Device Recall GE SIGNA Pioneer
  • 모델명 / 제조번호(시리얼번호)
    Mfg Lot or Serial # System ID  001612TA1 N/A 001718TA6 336397P3T  002331TA7 083132425984 001719TA4 250598MR1 001424TA1 M2850013 001537TA0 TP0008MR07 001662TA6 157022MR01 001184TA1 ZC0002 001652TA7 N/A 002227TA7 ZC0003 002278TA0 ZC0004 002330TA9 ZC0006 002529TA6 N/A 001485TA2 34026MRS05 002279TA8 34225MRS02 002395TA2 34185MRS02
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide in the states of SC, NC and the countries of Australia, Canada, France. Germany, Japan and Turkey.
  • 제품 설명
    SIGNA Pioneer MR Systems || Product Usage: || The SIGNA Pioneer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the SIGNA Pioneer reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
  • 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