Device Recall InGenuity CT System 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
    61102
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1046-2012
  • 사례 시작날짜
    2011-12-08
  • 사례 출판 날짜
    2012-02-16
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2013-03-01
  • 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 JAK
  • 원인
    Design defect. philips learned of this device issue following their receipt of a customer complaint reporting that a 'gap' is created in the side covers when the gantry of the device is tilted to +30 degrees (forward tilt). a hazard to the operator/user presents itself if the operator puts his or her fingers or hand inside the gap and the gantry tilt is returned in position while the fingers or.
  • 조치
    The firm, Philips, sent an 'URGENT - Medical Device Correction Ingenuity CT***' letter dated December 08, 2011. The letter describes the affected product, the nature of the problem along witth the circumstances under which this problem can occur; the hazard involved and actions to be taken by the customer/user. The customers (operator/users) were instructed not to insert hands in the gap which will be located between the gantry and stationary support column located on either side of the CT System (illustrations are provided). The letter notifies the customers that a Philips representative will be visiting each customer site and installing a hardware upgrade through a Field Change Order. For further information or support concerning this issue contact your local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customer Care Solutions Center at (1-800-722-9377, option 5; enter site 10 or follow prompts).

Device

  • 모델명 / 제조번호(시리얼번호)
    The following Serial Numbers are subject to recall/software correction: 300003, 300004, 300005, and 300010.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) including states of: IN and OR; and countries of: Australia and Germany.
  • 제품 설명
    Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300003, 300004, 300005, and 300010. || Product Usage: The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-a¿sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
  • Manufacturer

Manufacturer

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