Events

Ingenuity Core128 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-2384-2016
  • 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=148428
  • 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 Core128
  • 모델명 / 제조번호(시리얼번호)
    Ingenuity Core128 Model No. 728323 S/N:30023 30151 32000 32001 32008 32061 32065 32067 32076 32162 52023 52028 52049 336177 30016 32012 32042 32044 32057 32068 32069 32100 32106 32138 32139 32140 32141 32142 32143 32144 32145 32146 32147 32148 32149 32150 32151 32152 32153 32154 32155 32156 32157 32158 32159 32160 32161 32163 32164 32165 32166 32167 320001 320003 320006 320008 320010 320024 320026 320029 320031 320037 320054 320078 320090 320092 320107 320202 320224 320225 320226 320227 320228 320229 320230 320231 320232 320233 320234 320235 320236 320238 320239 320240 320241 320242 320243 320245 320246 320247 320248 320250 320251 320252 320254 320255 320256 320258 336011 336012 336015 336016 336018 336025 336027 336028 336029 336034 336040 336044 336068 336072 336076 336092 336100 336102 336104 336142 336148 336149 336150 336151 336152 336153 336154 336155 336156 336157 336158 336159 336160 336161 336162 336163 336164 336166 336167 336168 336170 336171 336172 336173 336174 336175 336176 336178 336180 336181 336182 336183 336184 336185 336186 336188 336190 336192 336193 336194 32010 32013 32015 32016 32018 32021 32024 32026 32028 32032 32033 32034 32036 32037 32041 32043 32046 32047 32048 32049 32050 32051 32052 32053 32054 32055 32056 32058 32059 32060 32062 32063 32064 32070 32071 32072 32073 32074 32075 32077 32078 32079 32080 32081 32082 32084 32085 32086 32087 32088 32089 32090 32091 32092 32093 32094 32095 32096 32097 32098 32099 32101 32102 32103 32104 32105 32108 32109 32110 32111 32112 32113 32114 32115 32116 32117 32118 32119 32120 32121 32122 32123 32124 32125 32126 32127 32128 32129 32130 32131 32132 32133 32134 32135 32136 32137 32168 320002 320005 320018 320030 320033 320058 320059 320069 320073 320074 320079 320081 320082 320083 320084 320088 320096 320099 320100 320101 320103 320111 320114 320115 320119 320122 320123 320125 320126 320128 320129 320131 320132 320133 320134 320138 320144 320146 320147 320200 320201 320203 320204 320222 320223 320237 320260 320261 320262 320263 320264 320265 320266 320267 320268 320269 336013 336017 336023 336046 336051 336059 336060 336064 336066 336067 336069 336070 336071 336073 336075 336077 336078 336079 336080 336081 336082 336083 336084 336085 336086 336087 336088 336089 336090 336091 336093 336094 336095 336096 336097 336098 336099 336101 336103 336105 336106 336107 336108 336109 336110 336111 336112 336114 336115 336116 336117 336118 336119 336120 336122 336123 336124 336125 336126 336127 336128 336129 336130 336131 336132 336133 336134 336135 336136 336137 336138 336139 336140 336141 336143 336144 336145 336146 336147 336169 336202 336203 336204 336206 32066 320136 320216 320253 320257 320270 320271 320272 320273 320274 320275 320278 320279 336113 336187 336189 336198 336201 336205 336207 336209 336210 336211 336212 336217 336220 336221 336228 336232
  • 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 Core128 Model No. 728323; 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