Events

Device Recall Helix 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
    65579
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1789-2013
  • 사례 시작날짜
    2013-06-13
  • 사례 출판 날짜
    2013-07-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-06-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119628
  • 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
    Ge became aware of an incident at a va medical center facility in the us in which a patient died due to injuries sustained while being scanned on an infinia hawkeye 4 nuclear medicine system.
  • 조치
    GE sent an Urgent Medical Device Correction letter dated June 17, 2013 to all affected customers. The letter identified the affected product, recommended that qualified service personnel maintain the equipment and that Preventative Maintenance procedures are executed according to labeling. Also the Safety Chapter Sections should be re-reviewed with personnel to ensure proper operation of the equipment. GE notified customers again on July 03, 2013, via Urgent Medical Device Recall letter (including confirmation of delivery for US customers) and follow-up telephone call. Customers were instructed to cease using the affected system until GE Healthcare Field Engineer can complete an inspection of the system and perform any necessary repairs at no cost. A GE Healthcare representative will contact the hospitals to arrange for the inspection.

Device

Device Recall Helix
  • 모델명 / 제조번호(시리얼번호)
    System ID: 57503, 57584, 57588, 57711, 57727, 57734, 57815, 57873, 58826, 0828960002, 082426010006, 082426130005, 082426160008, 00243NUC09, 0090J, 0177A, 0201B, 0252A, 0272B, 0274B, 0279A, 0280A, 0286A, 030038NU04, 030151NU02, 030232NU04, 080019NU03, 210001NU01, 250565NUC2, 416586HELIX, 418589HELIX, 506739HELIX, 519464HELIX, 61420HELIX, A5110123, A5153605, AP2302NM01, B4213128, B5315316, CS1013NM01, FE8161EL18, IL1041NM01, IL1042NM02, IL1062NM02, M4148612, M4392002, MPX247EL09, NE4191EL15, PL1139NM01, SK1042NM01.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide including Guam, Puerto Rico and the countries of : Afghanistan, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Vietnam.
  • 제품 설명
    Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera || Product Usage: || The intended use of the Quasar system is 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 typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.
  • 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