Device Recall Philips Healthcare

  • Modèle / numéro de série
    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
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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
  • 1 Event

Fabricant

  • Adresse du fabricant
    Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
  • Société-mère du fabricant (2017)
  • Source
    USFDA

79 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    software version - 4.0.4, 4.1.2, 4.1.3.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    Philips Healthcare DigitalDiagnost stationary X-ray system
  • Manufacturer
  • Modèle / numéro de série
    software version - 4.0.2, 4.0.3, 4.0.4 into 4.0.5
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    Philips Healthcare DuraDiagnost stationary X-ray system
  • Manufacturer
  • Modèle / numéro de série
    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
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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
  • Description du dispositif
    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
  • Modèle / numéro de série
    728243  Brilliance BigBore Oncology CT  7116 7611 7354 7063 7309 7169 7205 7016 7019 7043 7069 7073 7091 7112 7132 7163 7141 7194 7226 7325 7294 7350 7316 7480 7114 7210 7310 7438 7530 7186 7119 7042
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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
  • Description du dispositif
    Brilliance CT Big Bore Oncology, Model number 728243 || 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
  • Modèle / numéro de série
    728244  Brilliance BigBore Radiology CT   7375 7781 7614 7633 7708 7789 7721 7760 7252 7380 7390 7514 7052 7244 7384 7533 7172 7200 7546 7427 7452 7407 7453 7586
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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
  • Description du dispositif
    Brilliance BigBore Radiology CT Model number 728244 || 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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