Device Recall Brilliance CT 6, Brilliance CT 16, Brilliance CT 40, & Brilliance CT 64

  • Modèle / numéro de série
    Model #, 728231, Serial #: 4021, 9535, 9544, 9587, 9627, 9701, 9707, 9713, 9759, 9875, 9887, 9917, 9925, 9931, 9980, 9996, 10009, 10011, 10012, 10015, 10028, 10036, 10042, 10045, 10050, 10052, 10062, 10063, 10064, 10077, 10079, 10081, 10096, 10099, 10102, 10111, 10114, 10120, 10122, 10135, 10136, 10137, 10139, 10145, 10148, 10149, 10151, 10152, 10153, 10154, 10162, 10165, 10166, 10170, 10171, 10172, 10173, 10188, 10189, 10191, 10196, 10198, 10203, 10214, 10222, 10227, 10228, 10229, 10230, 10235, 10238, 10242, 10243, 10247, 10259, 10260, 10261, 10263, 10268, 10273, 10274, 10278, 10288, 10291, 10293, 10294, 10297, 10298, 10301, 10302, 10307, 10312, 10313, 10316, 10317, 10318, 10319, 10320, 10327, 10336, 10337, 10341, 10347, 10349, 10350, 10351, 10352, 10353, 10362, 10365, 10376, 10380, 10384, 10387, 10393, 10400, 10411, 10412, 10414, 10431, 10438, 10439, 10445, 10446, 10452, 10453, 10459, 10461, 10468, 10470, 10471, 10476, 10482, 10486, 10490, 10491, 10503, 10511, 10513, 10519, 10535, 10536, 10540, 10544, 10546, 10551, 10554, 10561, 10563, 10568, 10569, 10574, 10582, 10600, 10617, 10628, 10631, 10635, 10646, 10647, 10651, 10655, 10659, 10673, 10684, 10686, 10698, 10714, 10733, 10734, 29002, 29014, 29016, 29027, 90054, 90099, 95022, 95046, 95073, 95103, 95107, 95109, 95114, 95132, 95133, 95181, 95209, 95268, 95295, 95305, 95371, 95453, 95473, 95563, 95660, 95704, 95706, 95707, 95712, 95715, 95721, 95727, 95729, 95769, 95778, 90199 & 95162.  Model #, 728235, Serial #: 9034, 9190, 9233, 9234, 9261, 29049, 29057, 29064 & 29149.  Model #, 728246, Serial #: 3150, 3163, 4051, 5547, 5585, 5623, 5655, 5666, 5670, 5715, 5724, 5747, 5773, 5776, 5791, 5803, 5813, 5836, 5855, 5862, 5868, 5876, 5877, 5897, 5911, 5916, 5935, 5969, 5971, 5974, 5997, 6001, 6006, 6008, 6028, 6087, 6102, 6117, 6120, 6121, 6126, 6170, 6195, 6200, 6202, 6203, 6238, 6243, 6281, 6287, 6306, 6318, 6324, 6346, 6352, 6387, 6402, 6405, 6444, 6484, 6491, 6494, 6495, 6496, 6503, 6517, 6519, 6523, 6556, 6559, 6609, 6610, 6611, 6612, 6623, 6624, 6640, 6642, 50115, 50147, 50166, 50180, 50189, 50193, 50195, 50197, 50198, 50204 & 50043.  Model #, 728256, Serial #: 3490, 3500, 3679 & 3693.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, DE, FL, GA, IN, KY, MA, MD, MI, MN, MS, NC, NM, NV, NY, OH, OK, PA, SC, TN, TX, VT, WI & WV, and the countries of Australia, Austria, Bosnia & Herzegovina, Chile, China, Croatia, Denmark, Equatorial Guinea, France, Germany, Greenland, Iceland, Indonesia, Israel, Japan, Kazakhstan, Netherlands, Nigeria, Norway, Poland, Romania, South Africa, South Korea, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom & Vietnam.
  • Description du dispositif
    Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40, M/N 728235 & Brilliance CT 64 M/N 728231, Philips Healthcare, Cleveland, OH 44143. || Intended to produce cross-sectional images of the body by computer reconstruction.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Société-mère du fabricant (2017)
  • Source
    USFDA