FDA Device recall Z-1745-2014
Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance CT Big Bore Radiology Whole Body Computed Tomograp…
- FDA Device
- Class II
- terminated
- Published 2014-07-02
On 2014-07-02 the FDA classified a Class II recall of Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance CT Big Bore Radiology Whole Body Computed Tomograp… by Philips Medical Systems Cleveland, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1745-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-19 |
| Published | 2014-07-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | US |
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.
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.
Identifiers
| code_info | Brilliance CT Big Bore Oncology: Model #728243; Serial #s: 7185, 7187-7189, 7191-7199, 7201,-7243, 7245-7251, 7253-72…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, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1745-2014%22
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