Device Recall Philips Healthcare

  • Model / Serial
    Software versions: F.02, R.02, 9.xx or any earlier versions   Addendum Models: M3532A, M3535A, M3536AM, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 M3535A- HeartStart MRx Defibrillator Monitor M3536A- HeartStart MRx Defibrillator Monitor EtC02 Options A04 A05 A06 All M3532A Upgrade
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    US Nationwide and OUS.
  • Product Description
    Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement || 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. The HeartStart MRx EtCO2 Option monitors carbon dioxide (CO2) and measures end-tidal carbon dioxide (EtCO2). The option provides an EtCO2 value and a CO2 waveform on the devices display.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

79 devices with a similar name

Learn more about the data here

  • Model / Serial
    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
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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
  • Product Description
    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
  • Model / Serial
    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
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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
  • Product Description
    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
  • Model / Serial
    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
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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
  • Product Description
    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
  • Model / Serial
    728246 -- Brilliance 16  3010 3017 3031 3040 3043 3070 3072 3085 3090 3117 3149 3216 3247 3293 3314 5006 5012 5018 5020 5024 5026 5028 5030 5031 5035 5044 5045 5052 5053 5054 5055 5058 5059 5060 5064 5069 5070 5081 5086 5088 5091 5093 5097 5099 5103 5107 5108 5110 5111 5115 5116 5118 5120 5123 5126 5127 5128 5131 5138 5140 5155 5160 5161 5163 5166 5184 5186 5188 5190 5191 5192 5193 5195 5197 5208 5209 5216 5219 5235 5236 5238A 5270 5272 5279 5282 5285 5287 5294 5295 5315 5316 5350 5354 5357 5360 5368 5394 5433 5434 5443 5453 5457 5480 5487 5501 5502 5505 5519 5523 5526 5554 5572 5573 5576 5609 5615 5633 5647 5653 5683 5723 5758 5762 5764 5771 5811 5897 5929 5937 5956 5974 5995 6021 6022 6031 6033 6048 6053 6072 6220 6229 6243 6280 6283 6298 6309 6321 6360 6375 6405 6426 6441 6465 6474 6484 6503 6511 6517 6519 6523 6549 6559 30049 32287 50011 50053 50087 50180 3123 5674 6555 32366 3465 50181 5135 5237 3179 3411 5009 5048 5077 5412 6154 30011 30110 5101 5181 3324 5405 3050 3441 6387
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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
  • Product Description
    Brilliance 16, Model number 728246 || 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
  • Model / Serial
    728240 -- Brilliance CT 16 Power  3100 5043 5047 5280 5345 5390 5413 5430 5495 5499 5512 6007 6009 6013 6032 6041 6045 6049 6051 6058 6064 6066 6070 6071 6077 6080 6081 6084 6089 6095 6100 6106 6109 6113 6115 6116 6123 6124 6131 6132 6134 6141 6144 6155 6161 6162 5476 6098 6120 6067
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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
  • Product Description
    Brilliance CT 16 Power, Model number 728240 || 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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