Vertical drive brake 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
    50120
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0597-2009
  • 사례 시작날짜
    2008-09-23
  • 사례 출판 날짜
    2009-01-16
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-03-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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, tomography, computed - Product Code KPS
  • 원인
    The product is being recalled because the patient support may travel downwards without being commanded to move.
  • 조치
    A On 11/15/2007 & 6/6/2008 the firm sent Urgent Device Notification letters to their customers. They notified their customers that a Field Service Engineer will inspect and repair the brake system.

Device

  • 모델명 / 제조번호(시리얼번호)
    Assembly number 4535 664 98912.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and WV and countries of Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Canada, China, Colombia, Costa Rica, Czech Republic, Denmark, Egypt, England, France, Germany, Greece, China, India, Indonesia, Ireland, Iraq, Italy, Japan, Jordan, Korea, Lebanon, Libya, Lithuania, Malaysia, Malta, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, South Africa, South Korea, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
  • 제품 설명
    Vertical drive brake (on patient supports). Used on certain Philips Medical Systems MX series and Brilliance series CT scanners. || The device is a vertical drive brake that controls the vertical position of a patient support system or couch. The patient support system is intended to be used to place the patient in the correct horizontal and vertical position in order to be scanned. The couch is an accessory product to a computed tomography scanner.
  • Manufacturer

Manufacturer

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