Events

Device Recall GE Healthcare Prestige II 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
    75851
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0911-2017
  • 사례 시작날짜
    2016-11-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-09-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151914
  • 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, fluoroscopic, image-intensified - Product Code JAA
  • 원인
    Ge healthcare is conducting a recall due to the potential fall of aged crt monitors - prestige 2, prestilix, prestige vh, prestige si, rfx/sfx, legacy, precision 500d, advantx and innova 2000 systems.
  • 조치
    Consignees were sent on 11/21/2016 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# FMI 10913 dated November 21, 2016. The letter was addressed to Director of Radiology, Risk Manager/Hospital Administrator, and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Device

Device Recall GE Healthcare Prestige II
  • 모델명 / 제조번호(시리얼번호)
    Mfg. Lot or Serial # System ID 00000128555MO0 850526JR3 00000089643MO1 305227PRESTIGE1 00000094666MO5 305227PRESTIGE2 00000063792YY6 708216REM1 00000100104MO9 219416PRE 00000118238MO5 317338SVP 00000119906MO6 228314RF 00000113951MO8 662513RF2 Not Available 662513RF1 00000063697YY7 919472CGRFB 00000113961MO7 718262REM1 00000052137YY7 843692PRES 00000010115MO5 803778RF1 00000128514MO7 423493PRF4 Not Available 901226R9 Not Available 204623RF1 00000128614MO5 519685REM 00000063717YY3 905895RM3 00000113955MO9 905358REM 00000128544MO4 519631REM 00000128595MO6 326582XF1 00000063685YY2 082408040013 00000063685YY2 082408040013 00000063761YY1 082408100085 00000063716YY5 EG1024RX01 Not Available HDAR01XR02 00000128613MO7 IS1001RF01 00000063688YY6 A5181620 Not Available A5487204 00000063749YY6 B5130612 Not Available 0850080467 Not Available LY1006XR03 00000119921MO5 0853080154 00000063700YY9 0853080151 00000063700YY9 0853080151 00000119921MO5 0853080154 Not Available 38828380XRNOR 00000063753YY8 38811857XRAND 00000063767YY8 0859080008
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT,NC, NE NH, NJ, NM, NY, NV, OH, OK, PA, RI, SC, SD, TN, TX,, VA, WA, WO, WY, WV. OUS: Algeria Armenia Australia Austria Brazil Canada Chile China Denmark Egypt France Germany Guatemala Honduras Hong Kong Hungary Iceland India Ireland Italy Japan Korea Libya Mexico Netherlands Netherlands Peru Poland Portugal Russia Saudi Arabia Serbia Sierra Leone Slovakia Spain Taiwan Thailand Turkey United Arab Emirates United Kingdom Venezuela Vietnam
  • 제품 설명
    Prestige II
  • 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