Events

Device Recall Allura Xper FD10 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
    49488
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0124-2011
  • 사례 시작날짜
    2008-08-21
  • 사례 출판 날짜
    2010-10-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-11-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73599
  • 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
    Due to a potential geometry software lock up during a digital rotational angiography (dra) run, the stand and table movement may no longer be possible.
  • 조치
    Philips Medical Systems North America Co. sent an URGENT - Device Correction, dated September 15, 2010, to their consignees. The letter identified the product, the problem, and the action to be taken. The consignees were informed that there was a potential geometry software lock up during a Digital Rotational Angiography (DRA) run, the stand and table movement may no longer be possible. The consignees were advised that as geometry software errors happen intermittently, no actions can be performed by the consignees to minimize the risk except for not performing DRA procedures until the firm upgrades the software. For question consignees were to contact the Philips Call Center at 800-722-9377 #5, #4, #1 and reference FCO 72200111 or FCO 72200125.

Device

Device Recall Allura Xper FD10
  • 모델명 / 제조번호(시리얼번호)
    Devices are identified with Site Numbers:  14147, 38377, 505254, 544048, 544051, 548067, 549738, 550172, 552470, 552585, 552586, 553234, 553351, 553352, 553925, 554019, 554427, 554431, 554442, 554444, 554550, 554556, 554631, 554745, 554768, 554791, 555206, 556311, 556708, 556783, 557512, 41416358, 41443581, 41443882, 41444662, 41445645, 41446080, 41446144, 41446290, 41446807, 41455906, 41903960, 42393465, 43067304, 43719245, 44048177, and 44604746.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Devices were distributed to hospitals and medical facilities through out the U.S.
  • 제품 설명
    Allura Xper FD10 Monoplane X-ray system. || Intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA and stent placement and atherectomies), pacemaker implantations and electrophysiology. It is compatible with specified magnetic navigation systems.
  • 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