Events

Device Recall Pentax Medical Inc. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Pentax Medical Company 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
    68586
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2116-2014
  • 사례 시작날짜
    2014-06-12
  • 사례 출판 날짜
    2014-07-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-11-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128274
  • 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
    Gastroscope and accessories, flexible/rigid - Product Code FDS
  • 원인
    Aspiration needles used in combination with ultrasound gastroscopes can derail from the accessory elevator at the distal end of the endoscope. this may result in patient injury if the instruction for use is not followed carefully by the user.
  • 조치
    Pentax Medical sent an Urgent Medical Device Field Safety Corrective Action dated June 12, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. Pentax also posted their notification on their website. For questions regarding this action please feel free to contact Paul Silva, Recall Coordinator at Tel: 800-431-5880 ext 2064 (8:30am  5:00pm Mon-Fri, EST) Fax: 201-799-4063 Email : paul.silva@pentaxmedical.com

Device

Device Recall Pentax Medical Inc.
  • 모델명 / 제조번호(시리얼번호)
    Model: EG-3630U  A01013 E010080 E110111 E110159 E110236 A01017 E010082 E110116 E110161 E110237 A01022 E010084 E110118 E110167 E110239 A01025 E010092 E110120 E110169 E110240 A01026 E010093 E110132 E110172 E110256 A01028 E010094 E110134 E110177 E110277 A01029 E010095 E110135 E110179 E110278 A01031 E010096 E110138 E110182 E110282 A01033 E01037 E110139 E110187 E110283 A01036 E01038 E110140 E110188 E110285 E010064 E01039 E110141 E110193 E110287 E010066 E01042 E110144 E110195 E110289 E010069 E01043 E110145 E110202 E110290 E010070 E01046 E110146 E110205 E110306 E010075 E01054 E110147 E110208 E110307 E010077 E01061 E110156 E110210 E110308 E010078 E01062 E110157 E110219  Model: EG-3830UT  E110067 E110160 E110204 E110275 E110374 E110070 E110163 E110206 E110277 E110377 E110074 E110165 E110212 E110286 E110379 E110079 E110168 E110214 E110289 E110426 E110082 E110171 E110224 E110292 E110428 E110093 E110172 E110228 E110295 E110433 E110095 E110174 E110230 E110309 E110439 E110108 E110183 E110243 E110310 E110442 E110126 E110186 E110255 E110323 E110444 E110142 E110189 E110263 E110331 E110454 E110152 E110195 E110265 E110340 E110517 E110153 E110196 E110268 E110341  Model: FG-36UX  A01014 A01049 A01079 A01100 A01166 A01019 A01053 A01080 A01104 A01168 A01020 A01054 A01081 A01105 A01174 A01029 A01055 A01082 A01116 A01183 A01030 A01056 A01084 A01122 A01184 A01033 A01057 A01086 A01126 A01186 A01036 A01068 A01092 A01131 A110260 A01040 A01070 A01096 A01137 A110268 A01046 A01074 A01098 A01142  Model: EG-3870UTK  A110013 A110060 A110095 A110125 A110154 A110021 A110061 A110096 A110126 A110155 A110022 A110062 A110098 A110127 A110156 A110024 A110063 A110099 A110128 A110161 A110025 A110065 A110100 A110129 A110162 A110026 A110067 A110101 A110130 A110163 A110028 A110068 A110104 A110133 A110164 A110029 A110069 A110105 A110134 A110165 A110031 A110070 A110106 A110135 A110166 A110033 A110071 A110107 A110138 A110167 A110038 A110073 A110108 A110139 A110168 A110040 A110076 A110110 A110140 A110169 A110041 A110077 A110111 A110141 A110172 A110042 A110078 A110112 A110142 A110174 A110043 A110080 A110113 A110143 A110175 A110044 A110081 A110114 A110144 A110177 A110045 A110082 A110115 A110145 A110179 A110046 A110084 A110116 A110146 A110180 A110050 A110085 A110117 A110147 A110181 A110051 A110086 A110118 A110148 A110182 A110052 A110087 A110119 A110149 A110183 A110053 A110089 A110121 A110150 A110192 A110054 A110090 A110122 A110151 A110195 A110056 A110092 A110123 A110152 A110196 A110059 A110093 A110124 A110153 A110199 A110203 A110256 A110315 A110379 A110447 A110205 A110257 A110318 A110380 A110448 A110208 A110258 A110320 A110381 A110449 A110210 A110259 A110321 A110383 A110450 A110211 A110261 A110322 A110384 A110451 A110213 A110264 A110323 A110385 A110452 A110214 A110265 A110324 A110387 A110453 A110215 A110266 A110325 A110388 A110454 A110216 A110267 A110326 A110391 A110457 A110217 A110270 A110334 A110393 A110458 A110218 A110271 A110335 A110394 A110459 A110221 A110272 A110336 A110398 A110460 A110222 A110273 A110337 A110401 A110461 A110224 A110276 A110338 A110406 A110462 A110226 A110277 A110339 A110407 A110463 A110227 A110279 A110340 A110410 A110464 A110228 A110280 A110341 A110411 A110465 A110229 A110282 A110342 A110414 A110466 A110230 A110284 A110343 A110416 A110467 A110231 A110285 A110344 A110417 A110470 A110232 A110286 A110345 A110419 A110472 A110233 A110287 A110346 A110420 A110473 A110234 A110288 A110348 A110425 A110475 A110235 A110289 A110350 A110426 A110476 A110236 A110290 A110351 A110427 A110477 A110237 A110291 A110352 A110429 A110479 A110239 A110292 A110353 A110431 A110480 A110240 A110293 A110355 A110433 A110481 A110241 A110294 A110356 A110434 A110482 A110242 A110295 A110357 A110435 A110483 A110243 A110299 A110359 A110438 A110484 A110244 A110300 A110360 A110439 A110485 A110245 A110307 A110361 A110440 A110486 A110248 A110309 A110363 A110441 A110488 A110249 A110310 A110368 A110442 A110492 A110250 A110311 A110372 A110443 A110253 A110313 A110375 A110444 A110255 A110314 A110376 A110445
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    EG-3630U Ultrasound Video Gastroscope || EG-3830UT Ultrasound Video Gastroscope || EG-3870UTK Ultrasound Video Gastroscope || FG-36UX Ultrasound Fiber Gastroscope || Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
  • Manufacturer
    Pentax Medical Company

Manufacturer

Pentax Medical Company
  • 제조사 주소
    Pentax Medical Company, 3 Paragon Dr, Montvale NJ 07645-1782
  • 제조사 모회사 (2017)
    HOYA Corp.
  • Source
    USFDA