Events

Recall of Brilliance 64

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
    74427
  • Event Risk Class
    Class 2
  • Event Number
    Z-2116-2016
  • Event Initiated Date
    2016-04-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147502
  • 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
    Philips healthcare received reports from the field that certain brilliance 64 systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images. a patient rescan may be required if the images cannot be used for interpretation due to the swirl-like artifact.
  • Action
    Philips Medical Systems (Cleveland) Inc. sent an Urgent Field Safety Notice letter to affected customers , via certified letter with receipts returned for tracking purposes. The letter identified the affected product, problem and actions to be taken. Philips Healthcare is implementing software update version 3.5.5 to correct the problem. For questions contact your local Philips representative or local Philips Healthcare office.

Device

Brilliance 64
  • Model / Serial
    Brilliance 64: System Code #728231 Serial numbers: 9847, 9936, 9937, 9963, 10067, 10146, 10155, 10181, 10184, 10189, 10191, 10216, 10240, 10292, 10768, 10769, 10770, 10771, 10772, 10773, 10774, 10776, 10777, 10778, 10779, 10780, 10781, 10782, 10783, 10784, 10785, 10786, 10787, 10788, 10789, 10790, 10791, 10794, 10804, 10807, 29026, 29048, 29065, 29081, 29118, 29151, 91003, 95116, 95142, 95523, 95571, 95660, 95838, 95839, 95840, 95841, 95842, 95843, 95845, 95846, 95847, 95848, 95849, 95850, 95851, 95852, 95853, 95854, 95855, 95856, 95857, 95858, 95863, 95866, 95870, 95871, 95872, 95873, 95877, 95882, 95884, 95885, 95886, 95888, 95889, 95890, 95891, 95892, 95893, 95895, 95896, 95897, 95939, 6000861, 9208A, 9081
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of CA, FL, ID, KS, MI, NY,OH,TX
  • Product Description
    Brilliance 64, Computed Tomography X-ray system || Product Usage: || The Brilliance CT 64 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes
  • 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