Events

Recall of Device Recall Philips Brilliance CT Big Bore Oncology and Philips Brilliance CT Big Bore Radiology

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
    67879
  • Event Risk Class
    Class 2
  • Event Number
    Z-1745-2014
  • Event Initiated Date
    2013-12-19
  • Event Date Posted
    2014-06-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126548
  • 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
    During internal testing, the brilliance ct big bore was found to be out of tolerance for radio frequency emissions. specifically, at the 48mhz frequency, the testing indicated the brilliance ct big bore was 3.5db uv/meter higher than the applicable iec 60601-1-2 standard specification.
  • Action
    Philips Medical System sent an Urgent Medical Device Corrections letters dated December 10, 2013 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers that a field service Engineer will visit the facility to perform an Electro-Magnetic Interference (EMI) noise reduction up0date on each system. For information or support concerning contact your local Philips representative: For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, OptionS: Enter site ID or follow prompts).

Device

Device Recall Philips Brilliance CT Big Bore Oncology and Philips Brilliance CT Big Bore Radiology
  • Model / Serial
    Brilliance CT Big Bore Oncology: Model #728243; Serial #s: 7185, 7187-7189, 7191-7199, 7201,-7243, 7245-7251, 7253-7267, 7269, 7270, 7272-7297, 7299, 7300, 7302, 7304-7317, 7319-7374, 7376-7379, 7381, 7382, 7385, 7387-7389, 7391-7393, 7395, 7397-7401, 7403-7406, 7409-7429, 7431-7433, 7435-7438, 7440-7451, 7454-7457, 7459, 7462-7485, 7487-7509, 7511-7513, 7515-7519, 7521-7524, 7526-7528, 7530-7532, 7534-7537, 7539-7542, 7544, 7545, 7547, 7549-7556, 7558-7562, 7564-7566, 7568, 7569, 7573, 7574, 7577-7582, 7584, 7585, 7588-7593, 7596-7599, 7601-7603, 7605, 7608, 7609, 7611-7613, 7615-7618, 7620, 7622-7624, 7626-7630, 7634, 7635, 7637-7648 & 75000.  Brilliance CT Big Bore Radiology: Model #728244; Serial #s: 7190, 7200, 7244, 7252, 7268, 7271, 7301, 7318, 7375, 7380, 7383, 7384, 7386, 7390, 7396, 7402, 7407, 7408, 7427, 7430, 7439, 7452, 7453, 7458, 7486, 7510, 7514, 7520, 7525, 7529, 7533, 7538, 7543, 7546, 7557, 7570-7572, 7575, 7576, 7583, 7586, 7587, 7595, 7600, 7604, 7607, 7610, 7614, 7619, 7621, 7625, 7631-7633 & 7636.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI & WV. and countries of Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Ecuador, France, French Polynesia, Gabon, Germany, India, Indonesia, Israel, Italy, Jordan, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Martinique, Mexico, Morocco, Netherlands, New Zealand, Oman, Palestine, Philippines, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syrian Arab Republic, Thailand, Ukraine & United Kingdom.
  • Product Description
    Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance CT Big Bore Radiology Whole Body Computed Tomography X-Ray System. || Product Usage: || The Brilliance CT Big Bore is a Whole Body Computed Tomography X-Ray System which produces cross-sectional body images 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