Events

Ingenuity CT 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
    74131
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2385-2016
  • 사례 시작날짜
    2016-04-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-07-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148429
  • 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
    Software issues in v4.1.3/4.1.4/4.1.5 in the philips ingenuity ct products that could affect the performance of the equipment.
  • 조치
    The customers will be sent a letter with information about, what the problems are and under what circumstances they may occur, the actions customers can take to minimize the effect of the problem and the actions planned by Philips to correct the problem. To correct these issues, a Philips field service representative will install a software update on the affected systems. Reference field change order (FCO) 72800652.

Device

Ingenuity CT
  • 모델명 / 제조번호(시리얼번호)
    Ingenuity CT Model No. 728326 S/N:300004 30003 30005 30006 30007 30008 30009 30010 30011 30012 30013 30014 30015 30017 30018 30019 30020 30021 30022 30025 30026 30027 30028 30029 30030 30031 30032 30033 30034 30036 30037 30038 30039 30040 30041 30042 30043 30044 30045 30046 32083 300015 300033 300037 300038 300045 300054 300057 300066 300068 300072 300081 300082 300084 300089 300091 300107 300109 300120 300122 300141 300142 300149 300150 300156 300157 300207 300208 300209 300210 300211 30004-132107 52060 300003 300005 300010 300011 300012 300013 300014 300016 300017 300018 300019 300020 300021 300022 300024 300025 300027 300028 300029 300030 300031 300032 300034 300035 300036 300039 300040 300041 300042 300043 300044 300047 300049 300050 300051 300052 300053 300055 300056 300058 300059 300060 300061 300062 300063 300064 300065 300069 300070 300071 300073 300074 300075 300077 300078 300079 300080 300083 300086 300087 300088 300090 300092 300093 300094 300095 300096 300097 300098 300099 300100 300101 300102 300103 300104 300105 300106 300108 300110 300111 300112 300113 300114 300115 300116 300117 300118 300119 300121 300123 300124 300125 300126 300127 300128 300129 300130 300131 300132 300133 300135 300136 300137 300138 300139 300140 300143 300144 300145 300147 300148 300151 300158 300159 300160 300161 300162 300163 300164 300165 300166 300200 300201 300202 310058 310144 333057 336061 336084 336121 30047 52051 300213 300214 300216 300217 600023 600047
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also shipped to the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, Colombia, Cuba, Estonia, Finland, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.
  • 제품 설명
    Ingenuity CT Model No. 728326; To produce cross-sectional images of the body.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • 제조사 주소
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA