Z-1745-2014Class II

Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance CT Big Bore...

Name: Z-1745-2014 Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance CT Big Bore...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2013-12-19
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2013-12-19 / Terminated / root cause: manufacturing process

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance CT Big Bore Radiology Whole Body Computed Tomography X-Ray System... on 2013-12-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1745-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-19
Posted: 2014-06-22
Terminated: 2015-08-25
Recalling firm: Philips North America LLC
Product: 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.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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).
Quantity in commerce: 454 Units
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 codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1745-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1745-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-21

Product code JAK

K033357Class IIAcqsim-Multislice-CT, Model 453567042271Philips Medical Systems (Cleveland), Inc. / cleared 2004-01-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)