CLASS II Device recall · Reported 2 Jul 2014 · FDA Enforcement Report
Brilliance CT Big Bore Oncology Whole Body Computed recalled
Philips Medical Systems (Cleveland) is recalling Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance, distributed nationwide in the US. The recall was initiated on 19 Dec 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1745-2014
- FDA event ID
- 67879
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Dec 2013
- FDA classified
- 21 Jun 2014
- Reported
- 2 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 19 Dec 2013 | Recall initiated by company | |
| 21 Jun 2014 | Classified by FDA | +184 days |
| 2 Jul 2014 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesota
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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