Device Recall Philips Healthcare

  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers within the range of US00442485 through US00469873.   The following additional units are also affected because their energy select switches were replaced within the relevant time period: Serial Numbers:  US00100353 US00110688 US00121145 US00338153 US00100741 US00110914 US00121658 US00439208 US00100843 US00111399 US00123159 US00439504 US00101080 US00112143 US00124026 US00439652 US00101500 US00112685 US00125012 US00439661 US00102492 US00114680 US00125049 US00439688 US00102580 US00114900 US00125344 US00439930 US00102583 US00116677 US00126424 US00441252 US00102601 US00116965 US00127322 US00441758 US00102643 US00117003 US00127620 US00441855 US00103225 US00118060 US00213344 US00441862 US00103916 US00118260 US00213559 US00104178 US00118602 US00230434 US00105134 US00118915 US00230588 US00106329 US00118985 US00231849 US00106922 US00119444 US00232228 US00108281 US00119624 US00232394 US00108296 US00120241 US00233505 US00109777 US00120466 US00234442 US00110403 US00120589 and US00234615.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- UNITED STATES, CANADA, ALBANIA, ARGENTINA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA & HERZEGOWINA, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, DOMINICAN REPUBLIC, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY,GREAT BRITAIN, GREECE, GUADELOUPE, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN,KAZAKHSTAN, KENYA, KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MACAU, MACEDONIA, MALAYSIA,MALI, MARTINIQUE, MAURITIUS, MEXICO, MONGOLIA, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, OMAN, PALESTINE, PANAMA, PARAGUAY, PERU,PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO,ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, TANZANIA,THAILAND, TRINIDAD AND TOBAGO, TURKEY,TUNESIA, TURKMENISTAN, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, VIETNAM, VIRGIN ISLANDS and YEMEN.
  • 제품 설명
    HeartStart XL Model M4735A Defibrillator, Automatic, External || Defibrillator-Monitor. || The defibrillator/monitor is a fully featured defibrillator intended for use by qualified medical personnel trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 79 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Software Revision:K.21.54 or L.00.96
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - Nationwide Distribution and to the countries of : Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iran ( Islamic Republic of ) Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Morocco, Myanmar(Burma) Netherlands Antilles, Norway, Oman, Pakistan, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Province of China, Thailand, Turkey, United Arab Emirates, United Kingdom and Vietnam.
  • 제품 설명
    Philips IntelliVue Measurement Module X1 || Model: M3001A
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Software Revision: K.21.54 or L.00.96
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - Nationwide Distribution and to the countries of : Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iran ( Islamic Republic of ) Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Morocco, Myanmar(Burma) Netherlands Antilles, Norway, Oman, Pakistan, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Province of China, Thailand, Turkey, United Arab Emirates, United Kingdom and Vietnam.
  • 제품 설명
    Philips IntelliVue Module Measurement X2 || Model: M3002A
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    software version - 4.0.4, 4.1.2, 4.1.3.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA (nationwide) Distribution to the states of : ( DuraDiagnost) to the states of : OH, CA, WA and NE. (DigitalDiagnost) to the states of : AK, AZ, AL, CA, CT, CO, DE, FL, GA, HI, ID, KY, LA, MA, MN, MD, MS, ME, MO, NE, NY, ND, OH and PA.
  • 제품 설명
    Philips Healthcare DigitalDiagnost stationary X-ray system
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    software version - 4.0.2, 4.0.3, 4.0.4 into 4.0.5
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA (nationwide) Distribution to the states of : ( DuraDiagnost) to the states of : OH, CA, WA and NE. (DigitalDiagnost) to the states of : AK, AZ, AL, CA, CT, CO, DE, FL, GA, HI, ID, KY, LA, MA, MN, MD, MS, ME, MO, NE, NY, ND, OH and PA.
  • 제품 설명
    Philips Healthcare DuraDiagnost stationary X-ray system
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    9033 9037 9043 9045 9064 9065 9070 9075 9086 9089 9104 9108 9120 9151 9156 9172 9190 9243 9259 9507 9508 9511 9526 9530 9531 9534 9547 9564 9580 9584 9598 9603 9606 9608 9613 9614 9630 9642 9655 9672 9695 9697 9690 9706 9713 9732 9735 9736 9757 9759 9812 9830 9835 9866 9875 9881 9889 9918 9936 9937 9951 9965 9968 9969 9975 9978 9992 9999 10036 10041 10046 10054 10067 10070 10080 10095 10103 10125 10141 10256 10292 10359 10363 10372 10380 10381 10386 10426 10473 10486 10505 10513 10527 10535 10561 10570 10645 10651 10655 10673 10686 10733 10743 10773 10776 29007 29016 29018 29025 29027 29037 29053 29097 90031 90047 90063 90128 95003 95058 95068 95210 95357 95811 29054 9107 9666 9700 29038 9858 9009 9029 9038 9051 9058 9067 9068 9072 9073 9092 9105 9106 9502 9503 9512 9516 9522 9525 9533 9545 9550 9551 9556 9572 9577 9591 9594 9596 9612 9618 9620 9624 9625 9626 9628 9633 9634 9635 9639 9641 9648 9650 9663 9676 9678 9685 9691 9692 9694 9705 9716 9726 9729 9740 9750 9751 9752 9753 9754 9775 9777 9780 9788 9790 9793 9809 9811 9821 9823 9826 9843 9846 9855 9857 9861 9869 9873 9878 9879 9882 9885 9894 9895 9902 9906 9917 9924 9938 9942 9948 9954 9960 9961 9966 9974 9982 9985 9994 10001 10014 10035 10037 10045 10065 10079 10085 10086 10096 10098 10111 10112 10113 10120 10148 10190 10200 10202 10224 10263 10291 10310 10332 10353 10365 10370 10371 10388 10413 10417 10424 29005 29035 29068 64015 90062 95008 95057 95348 9851T 10122 10373 10211 9139 10005 10026 10030 10031 10194 95149 95377 95392 9980 9698 9787
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution in the states of: AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA, MD,ME,MI,MN,MO,MS,NC,ND,NE,NJ,NM, NV,NY,OH,OK,OR,PA,PR,SC,TN,TX,UT,VA,VT,WA,WI,WV,WY
  • 제품 설명
    Brilliance 64 CT Model number 728231 || 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.
  • Manufacturer
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