Events

Vista Polaris 1.0T MRI 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
    49489
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2432-2010
  • 사례 시작날짜
    2008-09-19
  • 사례 출판 날짜
    2010-09-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-09-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73605
  • 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, nuclear magnetic resonance imaging - Product Code LNH
  • 원인
    Water may collect and freeze in the vent pipe. this can rupture the magnet vessel during a cryogen transfer, and release helium into the mri suite.
  • 조치
    Philips issued an Urgent Correction letter dated 09/19/2008 to their consignees, identifying the reason for the recall and the affected products. The firm issued the Field Change Order (FCO) 78100232. Field service engineers will visit each consignee and conduct an inspection of the magnets venting system of Edge, Vista, Eclipse, Polaris, Infinion, and Panorama 0.6T MRI systems. The consignees should contact the Philips Call Center at 1-800-772-9377, #5 #2 and reference "FCO 78100232".

Device

Vista Polaris 1.0T MRI
  • 모델명 / 제조번호(시리얼번호)
    64 units are identified as Site Numbers: 207065, 212785, 220006, 505407, 223017, 205895, 204190, 205768, 220999, 238085, 205525, 238028, 204948, 223009, 223002, 220037, 209625, 218044, 238212, 209558, 205770, 238069, 205649, 217569, 205578, 204510, 212961, 220029, 203039, 209543, 205581, 209621, 204151, 238251, 205643, 209282, 220024, 209658, 205579, 203525, 223267, 238139, 204535, 203519, 223033, 205769, 238008, 204902, 223028, 238024, 209573, 209622, 205724, 220021, 220032, 218137, 220023, 204539, 238031, 209695, 209719, 209743, 238072, and 205825.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution: USA., including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY. There is no distribution to foreign consignees.
  • 제품 설명
    Polaris, Nuclear Magnetic Resonance Imaging System, Magnet Subsystem, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143, U.S.A.".
  • 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