Events

Device Recall GE Healthcare, MSK 1.5T Extreme MR Scanner Model AA5000 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
    59522
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0107-2012
  • 사례 시작날짜
    2011-08-29
  • 사례 출판 날짜
    2011-10-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103010
  • 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, nuclear magnetic resonance imaging - Product Code LNH
  • 원인
    Ge healthcare has recently become aware that an exposed high voltage gradient wire internal to the msk 1.5t extreme system equipment may cause electrical shock, which may impact service personnel safety. this issue does not impact patient or operator safety.
  • 조치
    GE Healthcare LLC sent a "Urgent Medical Device Correction letter" dated August 29, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed to please ensure that all potential service personnel at your facility are made aware of this safety notification and the recommended actions. Contact your local service representative if you have any questions concerning this notification. For further questions please call ( 262 ) 513-4122.

Device

Device Recall GE Healthcare, MSK 1.5T Extreme MR Scanner Model AA5000
  • 모델명 / 제조번호(시리얼번호)
    06012008-001 12182008-001 12162008-001  03132009-001  03242009-001 05152009-001  07142009-001  08082009-001 09172009-001 12072009-001 10252009-001 01082010-001 012720100-001 03072010-001 03252010-001 04012010-001 05262010-001 06082010-001 06182010-001 09142010-001 11292010-001 10182010-001 12052010-001 08122009-001 09222009-001 02242010-001 10082009-001 02112010-001 10222010-001 08132009-001 12222010-001  06192009-001 10312010-001 10142009-001 09222010-001 10012009-001 06042009-001  06062009-001 09072009-001 01182010-001 03012010-001 07272010-001 09132010-001 10082010-001 11162010-001 12152009-001 12242009-001 12142009-001 04302010-001 04082010-001 05072010-001 08152010-001
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (nationwide) including the states of AL, CA, FL, ID, NY, NH, NJ, NV, OH, PA, TX, VA and WI., and countries of UNITED ARAB EMIRATES, UKRAINE, UNITED KINGDOM, SWITZERLAND
  • 제품 설명
    GE HEALTHCARE, MSK 1.5T EXTREME MR SCANNER, MODEL AA5000. || The MSK Extreme TM MR Scanner is intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images of the internal structures of the leg (excluding the thigh), knee, ankle, foot, forearm, elbow, wrist and hand.
  • 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