Events

Device Recall Philips OmniDiagnost Eleva with Digital Image (DI) Rel.2 system 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems North America Co. Phillips 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
    57068
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0918-2011
  • 사례 시작날짜
    2009-03-06
  • 사례 출판 날짜
    2011-01-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-06-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95612
  • 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, angiographic - Product Code IZI
  • 원인
    Images from two different patients may be combined in one patient folder in the digital image (di) or may be combined as one (printed) image. it is possible that an image of a previous patient registered in the di will be overwritten with an image of a later patient.
  • 조치
    On March 6, 2009, Philips sent an "URGENT-Device Correction Easy Diagnost Eleva, MultiDiagnost Eleva, and OmniDiagnost Eleva with DI Rel. 2 systems notification" to their consignees/customers. The consignees/customers are advised that before diagnosing images, always check the stored (Digital Image, Viewform or PACS) or printed images to ensure that these represent the data and images captured from the examination of the respective patient. Do not use images if they do not represent the patient that was examined. Consignees will be contacted by Philips to schedule a software upgrade of their units. The consignees can contact Philips Healthcare Call Center at 800-722-9377, #5, #2 and reference "FCO 70800070" with any questions about this recall.

Device

Device Recall Philips OmniDiagnost Eleva with Digital Image (DI) Rel.2 system
  • 모델명 / 제조번호(시리얼번호)
    Site Numbers:   533530, 535118, 535257, 535924, 539106, 540860, 541490, 547017, 547142, 547348, 549798, 550258, and 553235.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: USA including states of: AZ, CA, CO, CT, DE, FL, GA, HI, ID, LA, MA, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OR, PA, SC, TN, TX, VA, WA, WI, and WY.
  • 제품 설명
    Philips OmniDiagnost Eleva with Digital Image (DI) Rel.2 system. || The Philips OmniDiagnost Eleva is a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications.
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

Philips Medical Systems North America Co. Phillips
  • 제조사 주소
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA