Events

Device Recall IGS 630 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
    67325
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0853-2014
  • 사례 시작날짜
    2013-11-15
  • 사례 출판 날짜
    2014-01-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-03-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125267
  • 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, X-Ray, Angiographic - Product Code IZI
  • 원인
    Ge healthcare has recently become aware of a potential safety issue with respect to igs 630 imaging systems. while performing fluoroscopy on a biplane fluoroscopy unit, there is a potential for loss of the x-ray imaging function when the user changes the size of the lateral fov (field of view) and releases the biplane footswitch pedal simultaneously. this could lead to a system lock up requiring.
  • 조치
    GE Healthcare sent an "Urgent Medical Device Correction" letter dated November 15. 2013. The letter was addressed to Hospital Administrators / Risk Mangers, Mangers of Radiology / Cardiology / Surgery Department and Radiologists / Cardiologists / Surgeons. The letter described the Safety Issue, Safety Instructions, Affected Product Details, and Product Correction. The letter stated that GE Healthcare will correct all affected systems at no cost. For questions call (In US 800-437-1171; for other countries contact your local GE Healthcare Service Representative).

Device

Device Recall IGS 630
  • 모델명 / 제조번호(시리얼번호)
    Serial # System ID 00000616724BU1 956389IGS630 00000618156BU4 MCMIGS630 FMI12200DUMMY2 702731ANGIO2 00000619372BU6 732828IGS30 00000618158BU0 210705CATH1 00000622076BU9 661327IGS630 00000621314BU4 904202WCL2 00000628656BU1 281MHWCL1 00000622220BU2 303839CL4 00000625357BU9 281420LAB3BP 00000626085BU5 817BGIGS630 00000628654BU6 215576IGS4 FMI12200DUMMY3 CS1340VA01 00000614683BU1 M4152252 00000618160BU6 YV1900 00000617143BU3 YV1901 00000618157BU2 YV1902 00000620495BU2 YV1903 00000624842BU1 YV1904 00000627935BU0 YV1905 00000630300BU2 YV1906 00000617142BU5 YV1950 FMI12200DUMMY4 YV1907 00000622672BU4 850060746 00000626239BU8 850060749 FMI12200DUMMY1 SA2308VA01 00000622221BU0 ZA2239VA01 00000614682BU3 34006VAS02
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide in the states of CA, CO, FL, NV, NJ, PA, TX and the countries of CZECH REPUBLIC, FRANCE, JAPAN, REPUBLIC OF KOREA, SAUDI ARABIA, and TURKEY.
  • 제품 설명
    GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imaging System. || Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures. The Cathiab Frontiers solutions are indicated for use in conjunction with single plane and biplane GE angiographic X-ray systems and imaging / data medical devices used in interventional and surgical cathlab environments and cleared for commercial distribution. The Cathiab Frontiers solutions are integrated GE angiographic X-ray and imaging / data medical devices that simplify the end-to-end clinical workflow in the cathlab by implementing: 1) Communication protocols for exchanging and automatically synchronizing patient, exam, system, and image information between the angiographic X-ray systems and the imaging / data medical devices. 2) Communication protocols for the control of imaging / data medical device functions from the angiographic X-ray systems user interface. 3) Interfaces for displaying the imaging / data medical device output on the monitor display solutions of the GE angiographic X-ray systems.
  • 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