Events

Philips Healthcare Brilliance iCT SP 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Healthcare 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
    74149
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1715-2016
  • 사례 시작날짜
    2015-09-06
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146515
  • 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
    Software defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when creating multi-planner reconstruction; (3) scan length changes with a change in field of view; (4) doseright algorithm miscalculations leading to incorrect ctdi values; (5) scan length changes during subsequent axial results, (6) surview scan lengths near 135mm or 184mm.
  • 조치
    Philips plans to initiate a field corrective action that will install a new software release to address the issue. Philips will modify the systems in the field to correct the defect at no cost to the customer. 1. You will contact customers and initiate a software update to correct the defect. 2. You will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that you will without charge, remedy the defect or bring the product into compliance. For further questions, please call (1-800) 722-9377, Option 5

Device

Philips Healthcare Brilliance iCT SP
  • 모델명 / 제조번호(시리얼번호)
    Software v. 4.13, 4.14 and 4.15.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution - AZ, PA, FL, DC, W VA, NC, SC, AR, OK, OH, NY, NV, TX, PA, IN, CA, MN, MA, DC, MS, MD, OR, IL, CO, MO, VT, IA, AL, LA, GA and WA.
  • 제품 설명
    Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • 제조사 주소
    Philips Healthcare, 3000 Minuteman Rd, Andover MA 01810-1032
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA