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
  • 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
  • 1 Event

제조사

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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 229 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Model M3535A: US00100100 to US00576623 Model M3536A: US00100902 to US00576650 Model M3536J: US00209838 to US00332675 Model M3536M: US00500002 to US00553553 Model M3536MC: US00500001 to US00500087 Model M3536M2: US00554176 to US00554178 Model M3536M4: US00500003 to US00574869 Model M3536M5: US00500001 to US00562935 Model M3536M6: US00554358 to US00576619
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide
  • 제품 설명
    HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 || Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Software systems Revision A.02.05 or lower
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) and countries: AUSTRALIA, AUSTRIA, BELGIUM, BULGARIA, CANADA, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, HUNGARY, ICELAND, INDIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, LUXEMBOURG, MOROCCO, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIAN FEDERATION, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • 제품 설명
    Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: || 866023 IntelliVue Info Center iX || 866024 PIIC iX Upgrade || 866117 PIIC Classic Upgrade || The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. || An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model/Serial Number Range:  Model M3535A: US00100100 to US00578696 Model M3536A: US00100902 to US00576650 Model M3536J: US00209838 to US00332675 Model M3536M: US00500002 to US00553553 Model M3536MC: US00500001 to US00500087 Model M3536M2: US00554176, US00554177, US00554178 Model M3536M4: US00500003 to US00574869 Model M3536M5: US00500001 to US00562935 Model M3536M6: US00554358 to US00576619
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide and the countries of AFGHANISTAN, ALBANIA, ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA AND HERZEGOWINA, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CAMBODIA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA (local name: Hrvatska), CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GERMANY, GHANA, GREECE, GUADELOUPE, HONG KONG, ICELAND, INDIA, INDONESIA, IRAN (ISLAMIC REPUBLIC OF), IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, Jordan, KAZAKHSTAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LAOS, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MACAU, MACEDONIA, MALAYSIA, MALTA, MEXICO, MONGOLIA, MOROCCO, MOZAMBIQUE, MYANMAR (Burma), NAMIBIA, NEPAL, NETHERLANDS, NETHERLANDS ANTILLES, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PALESTINE, PANAMA, PAPUA NEW GUINEA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, UNITED REPUBLIC OF TANZANIA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, TURKMENISTAN, UGANDA, UKRAINE, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • 제품 설명
    HeartStart MRx monitor/defibrillator || Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 || Product Usage: || The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    System : S/N : Model: 722003 30 Allura Xper FD10 722010 670 Allura Xper FD10 722011 167 Allura Xper FD10/10 722012 1951 Allura Xper FD20 722012 536 Allura Xper FD21 722012 504 Allura Xper FD22 722012 748 Allura Xper FD23 722012 536 Allura Xper FD24 722012 579 Allura Xper FD25
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide and the countries of: Canada,Australia, Austria, Brazil, Chile, China, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, South Africa, Spain, Switzerland and United Kingdom.
  • 제품 설명
    Philips Healthcare Allura Xper Series: || Allura Xper FD10 || Allura Xper FD10/10 || Allura Xper FD20 || Allura Xper FD21 || Allura Xper FD22 || Allura Xper FD23 || Allura Xper FD24 || Allura Xper FD25 || Product Usage: || The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and thrombolysis and atherectomics), pacemaker Implantations and electrophysiology (EP). Use of the Allura Xper series system in the OR environment is restricted; the system should only be used for endo-vascular procedures. The Philips Integris Allura 9F is intended for diagnostic cardiovascular, vascular and interventional procedures
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: SN120001 SN120002 SN120003 SN130001 SN130002 SN130004 SN130005 SN130015 SN130019 SN130021 SN130003 SN130006 SN130007 SN130009 SN130010 SN130011 SN130012 SN130013 SN130014 SN130016 SN130017 SN130018 SN130020 SN130022 SN130023 SN140001 SN130001 SN130002 SN140001 SN140004 SN140005 SN140008 SN140009 SN140010 SN140012 SN140013 SN140019 SN140020 SN140021 SN140022 SN140024 SN140027 SN140033 SN140034 SN140036 SN140053 SN140062 SN130003 SN140002 SN140003 SN140006 SN140007 SN140016 SN140017 SN140018 SN140031 SN140035 SN140037 SN140039 SN140040 SN140041 SN140044 SN140045 SN140046 SN140048 SN140050 SN140051 SN140052 SN140056 SN140058 SN140060
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution. Argentina, Australia, Burkina-Faso, Chile, China, Colombia, Ecuador, France, Germany, Hungary, Indonesia, Iraq (NL), Kuwait, Libya, Macedonia, Malaysia, Mayotte, Poland, Saudi Arabia, Slovenia, Spain, Switzerland, Turkey, United Kingdom, and Uzbekistan.
  • 제품 설명
    Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic || Models: 712210, 712211
  • Manufacturer
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