Events

Recall of Device Recall Philips

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems (Cleveland) Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66296
  • Event Risk Class
    Class 2
  • Event Number
    Z-0013-2014
  • Event Initiated Date
    2013-08-30
  • Event Date Posted
    2013-10-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121957
  • Notes / Alerts
    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.
  • Extra notes in the data
    System, x-ray, tomography, computed - Product Code JAK
  • Reason
    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
  • Model / Serial
    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.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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
  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA