Events

Device Recall MX 16slice 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
    63014
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2386-2012
  • 사례 시작날짜
    2012-08-24
  • 사례 출판 날짜
    2012-09-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-08-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112273
  • 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
    On august 24, 2012 the firm recalled the mx 16-slice after discovering that a bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry.
  • 조치
    An "Urgent Medical Device Correction" Field Safety Notice dated August 24, 2012 was sent to all US consignees via certified mail. The problem was described and recommended actions were provided. Philips Key Market representatives distributed the letter internationally. Additionally, a Field Service Engineer will contact each site to schedule time to implement the Field Change Orders. US Customer contact number: 1 800-722-9377.

Device

Device Recall MX 16slice
  • 모델명 / 제조번호(시리얼번호)
    System Code #, 728131, Serial #: EP16E090001-EP16E090004, EP16E090006-EP16E090015, EP16E100001- EP16E100004, EP16E100006, EP16E100008- EP16E100063, EP16E100067, EP16E100069- EP16E100113, EP16E110001- EP16E110065, EP16E110067-EP16E110070, EP16E110074-EP16E110075, EP16E110077-EP16E110078, EP16E110080, EP16E110083- EP16E110085, EP16E110088- EP16E110112, EP16E110115- EP16E110119, EP16E120001- EP16E120014, EP16E120016, EP16EB110003- EP16ER100007, EP16ER110003, EP16ER110006, P16C080001, P16C080002, P16C090001, P16C100001-P16C100015, P16C100017, P16C100018, P16C110001- P16C110008, P16C110011-P16C110037, P16C120001-P16C120003, P16C120006, P16C120007, P16E080005, P16E080007, P16E080008, P16E080012, P16E090002-P16E090021, P16E090024-P16E090028, P16E100002, P16EF80010, P16EM08003, and P16EM09002-P16EM09004.  System Code #, 728132, Serial #: EP16E100005, EP16E100007, EP16E110066, EP16ER100003-EP16ER100005, EP16ER100008, EP16ER110004, EP16ER110005, and EP16ER110007-EP16ER110024.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution, Nationwide (US) including the states AL, AR, CA, FL, GA, IL, IN, MS, NJ, NV, NY, OH, PA, and VA and the countries of Albania, Argentina, Australia, Belgium, Brazil, Chile, China, Colombia, Dominican Republic, Ecuador, France, Germany, Greece, India, Indonesia, Ireland, Italy, Jordan, Lebanon, Malawi, Mexico, Nepal, Netherlands, Oman, Palestine, Philippines, Poland, Romania, Russia, Saudi Arabia, South Africa, South Korea, Spain, Switzerland, Turkey, Uganda, and Venezuela.
  • 제품 설명
    MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system.
  • 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