Device Recall Infinia 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
    67464
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1198-2014
  • 사례 시작날짜
    2014-02-07
  • 사례 출판 날짜
    2014-03-13
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2014-11-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. this failure mode has been observed on a single system, in which the detector moved to the home position and then slowly starting drifting inward toward the patient. this generated both a visual and audio alert condition on both the console and the gantry. n.
  • 조치
    GE sent an Urgent Medical Device Correction letter, dated 2/7/2014 to medical facilities beginning 2/7/2014. The letter was addressed to Manager of Nuclear Medicine, Hospital Administrators/Risk Managers, and Managers of Radiology/Cardiology. The letter described the issue and provided safety instructions. For Infinia and Infinia Hawkeye, Millennium VG, VG Hawkeye and VariCam nuclear Medicine Systems, the letter stated that a software upgrade would correct the issue. For the Helix Nuclear Medicine Systems, GE stated that a software upgrade can not be applied to the older systems and that additional information will be provided at a later date. UPDATE ON THE HELIX DEVICES: An Urgent Medical Device Correction letter, dated 4/7/2014 was sent to customers who still have a GE Helix Nuclear Medicine System. The letter requested to immediately stop using the device, and reiterated the March 2008 letter in which GE stated that they would no longer be able to offer full service support. The main reason for this was due to unavailability of parts required for maintenance and repair of the device because outside suppliers cease to produce the older parts. GE offered assistance in removal and disposal of the Helix system.

Device

  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers for all devices: 22, 343, 1002, 1003, 1006, 1007, 1008, 1010, 1012, 1013, 1016, 1018, 1019, 1021, 1025, 1026, 1027, 1034, 1035, 1038, 1039, 1042, 1043, 1046, 1056, 1058, 1060, 1061, 1065, 1066, 1069, 1072, 1073, 1074, 1075, 1076, 1078, 1080, 1081, 1085, 1086, 1091, 1095, 1099, 1100, 1101, 1101, 1102, 1105, 1106, 1107, 1110, 1111, 1112, 1116, 1118, 1119, 1126, 1132, 1141, 1144, 1145, 1149, 1153, 1155, 1289, 1372, 1505, 1538, 1617, 1629, 1649, 1666, 1693, 1696, 1697, 1704, 1729, 1730, 1756, 1804, 1814, 1831, 1835, 1890, 1998, 1999, 3003, 5004, 5007, 8007, 10023, 10028, 10032, 10040, 10041, 10057, 10103, 10115, 10121, 10124, 10129, 10130, 10133, 10138, 10139, 10143, 10146, 10146, 10150, 10156, 10158, 10164, 10165, 10166, 10167, 10168, 10169, 10171, 10172, 10173, 10175, 10176, 10177, 10178, 10179, 10180, 10180, 10182, 10185, 10187, 10188, 10189, 10190, 10191, 10193, 10194, 10195, 10197, 10199, 10204, 10206, 10207, 10209, 10210, 10211, 10212, 10216, 10217, 10218, 10222, 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000003100-1829, 000003100-1838, 000003100-1840, 000003101-1502, 000003651-4185, 000003681-1803, 000003818-1210, 000003818-1224, 000003818-4187, 000008125-1630, 00000I92S08001, 00000ICPO50612, 00003618-12-26, 00003652-41-95, 00003817-11-12, 00003817-11-69, 00003818-11-41, 00003818-11-47, 00003818-11-82, 00003818-12-19, 00003818-32-02, 00008125-16-25, 00008125-16-70, 00008125-16-88, 00008125-16-89, 00008125-18-09, 00008125-18-10, 00008125-18-16, 00008125-18-18, 0000D4360X4372, 0003811-81-231, DUMFMI40849005, DUMFMI40849009, DUMFMI40849010, DUMFMI40849011, DUMFMI40849012, DUMFMI40849013, DUMFMI40849014, DUMFMI40849015, DUMFMI40849016, DUMFMI40849017, DUMFMI40849018, DUMFMI40849019, DUMFMI40849020, DUMFMI40849023, DUMFMI40849026, UNKASM00109200, UNKASM00109201, UNKASM00109204, UNKELS00000372.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including Puerto Rico and Guam and the countries of 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, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, and United Kingdom.
  • 제품 설명
    GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems. For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices 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 types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.
  • Manufacturer

Manufacturer

  • 제조사 주소
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
  • Source
    USFDA