Events

Device Recall Philips Medical Systems FVRF (Clinix RF Plus) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems (Cleveland) Inc 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
    75994
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1005-2017
  • 사례 시작날짜
    2016-11-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-07-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151897
  • 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, stationary - Product Code KPR
  • 원인
    There's a potential for liquid penetration into the back side of the front control panel of the x-ray diagnostic table, which can cause a short circuit of the terminals of the tilt operation and cause an unintentional tilt of the table.
  • 조치
    Philips sent an Urgent Field Safety Notice Medical Device Correction letter dated December 2, 2016 to customers via USPS certified letter with returned receipt. The letter identified the affected product, problem and actions to be taken. Additionally, your local Philips representative has been provided details regarding this Device Correction and can be contacted if you need any further information or support concerning this issue: Technical Support Line: 1-800-722-9377

Device

Device Recall Philips Medical Systems FVRF (Clinix RF Plus)
  • 모델명 / 제조번호(시리얼번호)
    System Serial Numbers:  0162R15403 0162A66105 0162A65401 218134 217530 209677 716334 217721 0162R16001 0162A65301 0162R15803 0162R16002 209669 0162R15504 0162R15602 0162A66104 0162R16007 0162R15802 0162R15702 0162R16003 212866 218047 0162A66005 0162R15603 0162R16004 218085 0162R15804 217296 0162A65402 0162P21004
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide distribution in the following states: AL, CA, FL, GA, HI, IL, IN, KS, LA, MA, MI, MS, NJ, NY, OH, PA, SC, VA, WI, WV, & WY.
  • 제품 설명
    FV-RF (Clinix RF Plus) || Product Usage: || A Stationary X-ray System, a device intended for radiographic/fluoroscopic examinations of various anatomical regions. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • 제조사 주소
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA