Events

Smith & Nephew 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Smith And Nephew, Inc. Endoscopy Division 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
    27738
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0248-04
  • 사례 시작날짜
    2003-10-10
  • 사례 출판 날짜
    2003-12-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-01-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30445
  • 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
    Accessories, Photographic, For Endoscope (Exclude Light Sources) - Product Code FEM
  • 원인
    Hardware of the camera coupler may rust and result in an ineffective sterilization/cleaning process.
  • 조치
    Smith & Nephew notified direct accounts by letter on 10/15/03. Service representatives will remove and replace product.

Device

Smith & Nephew
  • 모델명 / 제조번호(시리얼번호)
    Number: 7204614, Camera Coupler, C-Mount, 35mm F.L. Serial Numbers (QW prefix):   15601 16920 16981 18031 18066 18111 18143 18276 18354 15603 16924 16982 18032 18067 18112 18147 18278 18355 15604 16927 16983 18033 18068 18113 18149 18282 18358 15605 16932 16985 18035 18069 18114 18157 18283 18359 15607 16933 16987 18036 18070 18116 18158 18284 18362 15606 16935 16988 18039 18071 18118 18168 18288 18363 15609 16936 16989 18040 18072 18119 18169 18289 18370 15612 16950 16990 18041 18073 18120 18177 18291 18382 15617 16951 16991 18042 18074 18121 18187 18292 18391 15622 16957 16992 18043 18075 18122 18188 18295 18399 15623 16958 16993 18044 18076 18123 18189 18296 18445 15626 16961 16994 18045 18077 18125 18198 18300 18460 15630 16962 17005 18046 18078 18126 18199 18301 18461 16697 16964 17006 18047 18079 18127 18200 18303 18462 16713 16965 17025 18048 18080 18128 18201 18304 18464 16719 16966 17029 18049 18084 18129 18203 18306 18469 16720 16967 17030 18050 18088 18130 18204 18307 18470 16722 16968 17045 18051 18093 18131 18205 18308 18471 16726 16969 17050 18052 18097 18132 18206 18309 18476 16729 16970 17052 18053 18098 18133 18207 18310 18477 16797 16971 17068 18054 18100 18134 18209 18315 18478 16891 16972 17069 18055 18101 18135 18210 18325 18479 16897 16973 17092 18056 18102 18136 18212 18326 18480 16898 16974 17100 18057 18103 18137 18219 18336  16899 16975 18000 18059 18104 18138 18239 18342  16907 16976 18001 18060 18105 18139 18258 18346  16914 16977 18024 18062 18107 18140 18266 18351  16915 16978 18029 18063 18108 18141 18269 18352  16916 16980 18030 18064 18110 18142 18275 18353   Part Number: 7204614S, Camera Coupler, C-Mount, 35mm F.L. Serial Numbers (QW prefix): 18034 18096 18160 18259 18297 18383 18416 18434 18453 18038 18099 18161 18260 18313 18384 18417 18435 18454 18058 18106 18162 18261 18314 18385 18418 18436 18455 18061 18109 18163 18262 18316 18386 18419 18437 18456 18065 18115 18164 18263 18323 18393 18420 18438 18457 18081 18144 18165 18264 18324 18394 18421 18439 18458 18082 18145 18166 18267 18333 18395 18422 18440 18459 18083 18146 18167 18270 18334 18402 18423 18441 18463 18085 18148 18170 18272 18335 18403 18424 18442 18465 18086 18150 18171 18273 18344 18404 18425 18443 18466 18087 18151 18172 18274 18345 18405 18426 18444 18467 18089 18152 18231 18277 18356 18408 18427 18446 18472 18090 18153 18232 18279 18364 18411 18428 18447 18473 18091 18154 18246 18285 18366 18412 18429 18448 18474 18092 18155 18250 18287 18373 18413 18430 18450 18475 18094 18156 18256 18293 18374 18414 18431 18451  18095 18159 18257 18294 18376 18415 18433 18452
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide to hospitals Foreign: Australia, Africa, Belgium, Canada, China, Dubai, Egypt, Germany, D\Godmanchester, Italy, Japan, Korea, Malaysia, Norway, Portugal, Singapore, South Africa, Thailand, Taiwan.
  • 제품 설명
    Smith & Nephew Endocoupler C-Mount 35 mm Focal Length || Reference :7204614 and 7204614S (S indicates unit previously serviced)
  • Manufacturer
    Smith And Nephew, Inc. Endoscopy Division

Manufacturer

Smith And Nephew, Inc. Endoscopy Division
  • 제조사 주소
    Smith And Nephew, Inc. Endoscopy Division, 150 Minuteman Rd, Andover MA 01810-1031
  • Source
    USFDA