Events

Allura 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
    36573
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0165-2007
  • 사례 시작날짜
    2006-10-12
  • 사례 출판 날짜
    2006-11-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-09-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48924
  • 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
    x-ray and fluoroscopy - Product Code IZI
  • 원인
    Potential for generator to lock-up. fluoroscopy and x-ray is no longer possible, and system must be restarted to be able to continue.
  • 조치
    On 10/12/06 the firm issued a letter to their consignees advising of the problem and how to avoid the problem by using specific image formats. If the system should lock up, consignees are to switch the system off and then restart. The firm will be conducting software upgrades to the devices once software is ready (estimated time for FD 10/10 is November 2006 and estimated time for FD 20/10 is January 2007). Later, the firm identified 8 additional units and issued a letter on 12/11/06 to affected customers.

Device

Allura
  • 모델명 / 제조번호(시리얼번호)
    127, 113, 117, 112, 131, 128, 90, 17, 35, 137, 93, 51, 95, 27, 6, 47, 98, 22, 49, 39, 103, 120, 21, 40, 70, 101, 69, 94, 89, 23, 33, 31, 30, 29, 28, 32, 100, 63, 61 Additional units are identified with site numbers: 533397, 531926, 104950, 104953, 103283, 103281, 530653, 104497
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide.
  • 제품 설명
    Allura X-per FD 10/10 x-ray, and fluoroscopy
  • 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