Events

Device Recall GE Healthcare RFX 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-0915-2017
  • 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=151918
  • 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
    Table, radiographic, tilting - Product Code IXR
  • 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 RFX
  • 모델명 / 제조번호(시리얼번호)
    Mfg. Lot or Serial # System ID Not Available 818963RM4 00000026176YY8 213266SFX Not Available 209384MMRF 00000047956YY8 INSIGHTXR010 Not Available 818891VA1 Not Available 818891VA2 Not Available 2025761X46 Not Available 2025761X40 Not Available 813633RFX Not Available 813971RF6 Not Available 708259NWRF7 00000034249YY3 913596PR4 00000023702YY4 606327ADV Not Available 504867LRF2 Not Available 318388RF3 00000023806YY3 617735B6 00000022210YY9 313576RM1663 00000022218YY2 313576RM3622 Not Available 313576RM3645 Not Available 218726SMRF2 Not Available 601865RF1 Not Available 601865RF2 Not Available 601376OP3 Not Available 919681DB3 Not Available 919250WM9 00000026194YY1 706791D7 Not Available 914964SJRF 00000071239YY8 405271PRF4 00000022200YY0 215576RF18 00000128622MO8 615871SRF1 Not Available 817965HADV Not Available 713364W03 Not Available 206244RM2 00000022207YY5 EG1055VA01 00000022140YY8 SK1005RX05 00000023856YY8 AE1020RX01
  • 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
    RFX
  • 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