Events

Device Recall GE Healthcare Prestige VH 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-0913-2017
  • 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=151916
  • 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 VH
  • 모델명 / 제조번호(시리얼번호)
    Mfg. Lot or Serial # System ID Not Available 708425PREST 00000063646YY4 314525APR 00000034238YY6 910249LRF3 00000023833YY7 919472CGRFA 00000063653YY0 724284R4 00000052120YY3 713442KPDRS 00000063577YY1 509458DR10 00000048069YY9 AH4317XR04 00000052117YY9 AH3221XR06 00000026253YY5 AH5681XR02 Not Available CS1029RX01 00000113920MO3 EG1112RX05 00000023862YY6 M4159446 00000034208YY9 M4160037 Not Available M1875113 00000039660YY6 M4500608 00000048049YY1 M2880713 00000026209YY7 M4046528 Not Available M2838405 Not Available M2663805 00000089618MO3 M4202921 00000031488YY0 M9624214 00000023814YY7 M4496929 00000023829YY5 M4496929 Not Available B4192927 00000034269YY1 HC2834XR11 00000063668YY8 HC1627XR14 00000026202YY2 HC0393XR02 00000023796YY6 HC0760XR01 00000026216YY2 PC0545XR04 Not Available 490314XR02 Not Available MC5880XR03 Not Available CC2149XR02 Not Available IS1002RX01 00000063686YY0 IE1012RX03 00000063667YY0 IE1025RX02 Not Available IE1006RX07 00000063609YY2 A5250603 Not Available A5127805 00000034283YY2 NO1004RX01 00000026203YY0 NO1041RX01 Not Available NO1104RX01 00000048004YY6 NO1016RX02 00000080076YY3 PPR00132 00000063713YY2 PPR59013 00000026248YY5 RU1306RX01 00000063560YY7 CE165306 00000063616YY7 05074FLU02 00000063755YY3 38853103XRMET
  • 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 VH
  • 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