Events

Device Recall Brilliance CT XRay 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
    59383
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3281-2011
  • 사례 시작날짜
    2011-06-02
  • 사례 출판 날짜
    2011-09-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-03-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102462
  • 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
    Component defect. philips medical decided to conduct a recall field /correction (rework) of the mounting key locking threaded insert of the detector module system (dms) bolt on one (1) brilliance 64 ct x-ray unit. the firm initiated this action following philip's receipt of the customer's complaint reporting that the retaining inserts were pulling out of the rotor during the removal of the udms.
  • 조치
    Philips sent a Field Change Order (FCO) 72800519 on June 13, 2011 to the affected customer. A Field Service Engineer visited the customer site and installed a hardware upgrade to the affected Brilliance 64 device system (Serial Number: 9592). The correction action was completed on August 9, 2011. For questions regarding this recall call 1-440-483-7000.

Device

Device Recall Brilliance CT XRay System
  • 모델명 / 제조번호(시리얼번호)
    Model #78231, 510(k) #K03326, Serial Number: 9592.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including PA
  • 제품 설명
    Brilliance 64 Computed Tomography System, Model #78231, Serial Number: 9592. || The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

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