Events

Device Recall Philips 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Respironics Novametrix, LLC. 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
    57594
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2167-2011
  • 사례 시작날짜
    2011-01-04
  • 사례 출판 날짜
    2011-05-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-03-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96739
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • 데이터 추가 비고
  • 원인
    Software: two displayed respiratory parameters are incorrect due to errors in the system software: mvalv (alveolar minute ventilation) and vt/kg (tidal volume/patient weight). in both instances, the displayed parameters are higher than actual.
  • 조치
    Respironics issued Field Action Notification Letter via Fed'x on 1/4/11, notifying customers of the issue and to instruct them on conditions for continued use and return of the device. The device will be updated with revised software to correct the calculation errors. Any questions or need additional information about this recall action, Contact Respironics US Customer Service at 1-800-345-6443 for customers residing in the USA or +011 (203)697-6488 for International customers.

Device

Device Recall Philips
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 168-00041 168-00049 168-00055 168-00070 168-00071 168-00072 168-00073 168-00074 168-00075 168-00076 168-00077 168-00078 168-00079 168-00080 168-00081 168-00082 168-00083 168-00084 168-00085 168-00086 168-00087 168-00088 168-00089 168-00090 168-00091 168-00092 168-00093 168-00094 168-00096 168-00097 168-00098 168-00099 168-00100 168-00101 168-00102 168-00103 168-00104 168-00105 168-00106 168-00107 168-00108 168-00109 168-00111 168-00112 168-00113 168-00114 168-00115 168-00116 168-00117 168-00118 168-00119 168-00120 168-00121 168-00123 168-00125 168-00126 168-00127 168-00128 168-00129 168-00131 168-00132 168-00144 168-00145 168-00148 168-00164 168-00179 168-00181 168-00182 168-00183 168-00184 168-00186 168-00187 168-00188 168-00189 168-00190 168-00191 168-00193 168-00194 168-00195 168-00198 168-00203 168-00204 168-00205 168-00207 168-00208 168-00209 168-00211 168-00212 168-00218 168-00219 168-00222 168-00225 168-00237 168-00241 168-00242 168-00243 168-00244 168-00245 168-00246 168-00247 168-00248 168-00249 168-00250 168-00251 168-00252 168-00253 168-00254 168-00255 168-00256 168-00260 168-00261 168-00262 168-00263 168-00265 168-00266 168-00267 168-00269 168-00273 168-00274 168-00275 168-00277 168-00279 168-00280 168-00285 168-00286 168-00287 168-00288 168-00289 168-00290 168-00291 168-00293 168-00294 168-00295 168-00297 168-00298 168-00299 168-00300 168-00301 168-00302 168-00303 168-00304 168-00305 168-00306 168-00308 168-00309 168-00310 168-00311 168-00313 168-00314 168-00315 168-00316 168-00317 168-00318 168-00319 168-00320 168-00321 168-00322 168-00323 168-00331 168-00332 168-00333 168-00335 168-00336 168-00351 168-00352 168-00353 168-00354 168-00355 168-00357 168-00358 168-00359 168-00360 168-00361 168-00363 168-00364 168-00366 168-00367 168-00368 168-00369 168-00370 168-00373 and 168-00374
  • 의료기기 분류등급
    Anesthesiology Devices
  • 유통
    Nationwide Foreign: Belgium, China, Columbia, Egypt, England, India, Italy, Saudi Arabia, and Spain
  • 제품 설명
    Philips NM3 Monitors, Model 7900 || PHILIPS NM3 Monitor, English - P/N 1051674 || PHILIPS NM3 Monitor, English Refurbished - P/N U1051674 || PHILIPS NM3 Monitor, English, Demo Unit - P/N DU1051674 || PHILIPS NM3 Monitor, Spanish - P/N 1060462 || NM3 is a multi-parameter patient monitor that utilizes the FloTrak Elite module to perform some of the calculations.
  • Manufacturer
    Respironics Novametrix, LLC.

Manufacturer

Respironics Novametrix, LLC.
  • 제조사 주소
    Respironics Novametrix, LLC., 5 Technology Dr, Wallingford CT 06492-1942
  • Source
    USFDA