Events

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

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Philips Medical Systems (Cleveland) Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    65691
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2210-2013
  • Date de mise en oeuvre de l'événement
    2013-07-05
  • Date de publication de l'événement
    2013-09-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-09-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119893
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    System, x-ray, tomography, computed - Product Code JAK
  • Cause
    The patient support may move in an unintended manner if the footswitch cover impinges on the footswitch.
  • Action
    Philips Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated June 4, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the Customer Care Center at 1-800-722-9377, option 5 for information concerning this issue.

Device

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
    Radiology Devices
  • 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
    Philips Medical Systems (Cleveland) Inc

Manufacturer

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