Events

Rappel de Device Recall Philips

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
    66296
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0013-2014
  • Date de mise en oeuvre de l'événement
    2013-08-30
  • Date de publication de l'événement
    2013-10-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-05-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121957
  • 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
    There are artifacts appearing on the tracker images during threshold-triggered bolus scans with protocols using a rotation time of 0.4 seconds.
  • Action
    Philips sent an "Urgent - Medical Device Correction" letter dated August 30, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This Field Safety Notice is intended to inform you about: " what the problem is and under what circumstances it can occur " the actions that should be taken by the customer / user in order to prevent risks for patients or users " the actions planned by Philips to correct the problem If you need any further information or Support concerning this issue, please contact your local Philips representative or local Philips Healthcare office. For North America and Canada, contact the Customer Care Solutions Center (1 -800-722-9377, Option 5: Enter Site ID or follow the prompts). This notice has been reported to the appropriate Regulatory Agency. Philips apologizes for any inconveniences caused by this problem

Device

Device Recall Philips
  • Modèle / numéro de série
    System Code #728243, Serial #: 7040, 7083, 7087, 7123, 7124, 7133, 7170, 7178, 7204, 7231, 7273, 7328, 7365, 7370, 7395, 7434, 7467, 7596, 7612, 7775, 7794, 7795, 7840, 7841, 7842, 7843, 7846, 7847, 7848, 7849, 7850, 7851, 7852, 7854, 7855, 7856, 7857, 7858, 7860, 7861, 7863, 7864, 7865, 7866, 7867, 7868, 7871, 7872, 7873, 7875, 7876, 7877, 7881, 7883, 7884, 7885, 7886, 7889, 7890, 7891, 7892, 7893, 7895, 7896, 7898, 7900, 7901, 7902, 7904, 7905, 7907, 7908, 7909, 7910, 7911, 7912, 7914, 7915, 7916, 7918, 7920, 7921, 7923, 7924, 7926, 7927, 7928, 7930, 7931, 7932, 7934, 7935, 7936, 7937, 7938, 7940, 7941, 7942, 7943, 7944 and 7945. System Code #728244, Serial #: 7121, 7271, 7764, 7844, 7845, 7853, 7859, 7862, 7869, 7870, 7874, 7878, 7879, 7880, 7882, 7887, 7888, 7894, 7897, 7899, 7903, 7906, 7913, 7917, 7919 and 7922. System Code #728246, Serial #: 3079, 3090, 3127, 3410, 3478, 3500, 3679, 3721, 5067, 5072, 5073, 5143, 5317, 5439, 5663, 5728, 5741, 5928, 5971, 6028, 6052, 6061, 6067, 6090, 6107, 6133, 6147, 6153, 6156, 6162, 6231, 6491, 6556, 6606, 6607, 6608, 6609, 6610, 6611, 6612, 6613, 6614, 6615, 6616, 6617, 6618, 6619, 6620, 6621, 6622, 6623, 6624, 6625, 6626, 6627, 6628, 6629, 6630, 6631, 6632, 6633, 6634, 6635, 6636, 6637, 6638, 6639, 6640, 6641, 6642, 6643, 6644, 6645, 6646, 6647, 6648, 6649, 6650, 6651, 6652, 6653, 6654, 6655, 6656, 6657, 6658, 6659, 6660, 6661, 6662, 6663, 6664, 6665, 6666, 6667, 6668, 6669, 6670, 6671, 6672, 6673, 6676, 6678, 6679, 6680, 6681, 6682, 6683, 6684, 6685, 6689, 6695, 6696, 6697, 6707, 6710, 6711, 6714, 6721, 30075, 40013, 50026, 50043, 50177, 50181, 50182, 50189, 50195, 50198, 50200 and 60009.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AR, AZ, CA, CO, CT, GA, HI, IL, IN, KS, MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR,TN, TX, UT, VA, VT and WV., and the countries of Australia, Austria, Bangladesh, Belgium, Brazil, Chile, China, Denmark, Egypt, France, Germany, Honduras, India, Indonesia, Italy, Kazakhstan, Latvia, Lebanon, Libyan Arab Jamahiriya, Mexico, Netherlands, Norway, Palestine, Philippines, Poland, Russia, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom and Vietnam.
  • Description du dispositif
    Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) || Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) scanners are whole body Computed Tomography X-ray systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components and accessories.
  • 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