Events

Device Recall Philips Healthcare Ingenuity Core 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
    79666
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1406-2018
  • 사례 시작날짜
    2018-02-08
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162955
  • 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
    Closing the emergency stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
  • 조치
    The recalling firm notified customers of the recall on February 8, 2018, via Urgent Field Safety Notice. The notice advised customers of the issue and affected products and lot numbers. Customers were advised that once the E-stop has been closed, the operator/technologist must initate a brief horizontal motion (in or out) using any of the operator control panels, CT-Box or tape/foot switches. This action will ensure the couch carbon top (upper pallet) is in a controlled state. Customers were informed that a Field Service Engineer would contact them to schedule site updates to correct the issue. Customers who need further information or support were advised to contact their local Philips representative. Additionally, they may contact the Customer Care Solutions Center (1-800-722-9377.

Device

Device Recall Philips Healthcare Ingenuity Core
  • 모델명 / 제조번호(시리얼번호)
    Serial No. : 310204 310216 310264 52004 333094 52084 333060 333076 52069 333103 333110 333112 333064 52066 333142 310231 333096 333149 52053 333061 333062 333136 310383 52077 333093 310219 52065 310226 333092 333107 333108 310222 310206 310207 310225 310219 310226 310238 310317 310324 310330 310365 310337 310224 333072 333067 333074 333070 52065 333086 333085 333078 333079 333156 52075 52078 333088 33084 333083 333089 52083 333099 333098 333104 333101 52079 333106 333111 52082 333113 333123 333122 333121 333118 333124 333127 333125 333141 333147 333134 333137 333139 333155 333164 52052 333097 52014 333090 333132 333159 333073 52070 333080 333081 333087 333071 333126 333120 333140 333145 333146 333150 333151 333154 333082 52012 333056 333095 333117 310209 310245 333091 333109 333115 333105 333129 333138 333144 310214 52067 310318 52068 333066 333075 333131 333133 333163 52080 333114 333116 52081 52061 310239 310233 310366 310380 52056 52059 52063 52072 52071 52076 52064 333063 333068 333148 333152 333130 333059 333077 310347 333065 333119 52057 52058 52055 333102 333143 333153 310207 333100 333135 52054 310203 310299 310278 310277 310220 310319 310208 310213 310212 310217 310215 310274 310253 310267 310262 310241 310228 310258 310285 310249 310255 310294 310266 310243 310235 310363 310256 310289 310254 310292 310290 310283 310281 310301 310261 310271 310296 310227 310234 310259 310242 310286 310280 310232 310316 310287 310270 310273 310304 310282 310246 310269 310297 310303 310250 310295 310272 310260 310237 310221 310247 310229 310311 310305 310307 310308 310310 310309 310331 310322 310321 310364 310329 310335 310346 310334 310345 310350 310336 310344 310367 310279 310244 310298 310306 310275 310276 310284 310291 310288 310293 333071 310205 310210 310218 310300 310223 310265 310230 310236 310248 310257 310252 310240 310268 310263 310327 310251 310338 310343 310332 310016 310323 333079 310225 333078 336084 310315
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - U.S. Nationwide. International distribution to Canada, Mexico, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djibouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guyana, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Laos, Lebanon, Lithuania, Macedonia, Malaysia, Maldives, Mali, Martinique, Monaco, Mongolia, Myanmar, Nepal, Netherlands, New Calcedonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saint Pierre and Miquelon, Samoa, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, and Vietnam.
  • 제품 설명
    Ingenuity Core - Model no. 728321, Computed Tomography X-Ray system || Product Usage: || Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
  • 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