Events

Device Recall The Brilliance 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners 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
    65137
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1588-2013
  • 사례 시작날짜
    2013-03-21
  • 사례 출판 날짜
    2013-06-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-11-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118788
  • 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
    If the operator selects a patient name from the worklist using the mouse and then selects a different patient name using the keyboard (arrow keys then press enter) the patient name that populates the exam information page is the patient name selected with the mouse. also, it is possible to begin a normal clinical scan while the anti-virus scan is running. however, if the user is running a bol.
  • 조치
    Philips Medical Systems sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated Mar 21, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order.

Device

Device Recall The Brilliance 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners
  • 모델명 / 제조번호(시리얼번호)
    The following codes are affected by this recall:System Code #728231, Serial #: 9654, 91003, 95130, 95157, 95504  System Code #728326, Serial #:  32000,300003,300004,300005,300010,300011,300012,300013, 300014,300015,300018, 300027,300041,300053,300054, 300059, 300066, 300070,300071, 300073, 300074, 30077, 300078, 300079, 300080,300082,300084,300086,300091,300092, 300095, 300101, 300102,300112, 300119, 300127, 300128, 300129, 300131, 300132, 310064, 320030  System Code #728321, Serial #: 310096, 310070  System Code #728323, Serial #: 320033
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution-including the states of AR, AZ, DE, IN, KS, LA, MA, MN, MS, MT, NJ, NY, NY, OH, OR, PA, TN, TX, VT, WV, and WY.
  • 제품 설명
    Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems. || Produce cross-sectional images of the body by computer reconstruction of x-ray transmission.
  • 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