FDA Device recall Z-0009-2017
Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the bod…
- FDA Device
- Class II
- terminated
- Published 2016-10-12
On 2016-10-12 the FDA classified a Class II recall of Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the bod… by Philips Medical Systems, citing the infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0009-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-24 |
| Published | 2016-10-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems |
| Distribution | US |
Product
Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Reason
The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image quality manifested as non-uniformity of the image, CT number shift greater than 5 Hounsfield units, and reduction in gray/white matter differentiation. The issue is most sever in the High Resolution mode, and the factory reference pediatric scan protocols are set to High Resolution default. Adults head scans have a factory reference protocol that defaults to standard resolution which doesn't experience the issue.
Identifiers
| code_info | 4001, 4016, 5169, 9056, 9071, 9074, 9099, 9112, 9134, 9251, 9280, 9367, 9515, 9529, 9538, 9541, 9548, 9549, 9554, 9559,…4001, 4016, 5169, 9056, 9071, 9074, 9099, 9112, 9134, 9251, 9280, 9367, 9515, 9529, 9538, 9541, 9548, 9549, 9554, 9559, 9561, 9573, 9574, 9600, 9614, 9618, 9625, 9631, 9638, 9640, 9646, 9653, 9565, 9659, 9667, 9670, 9678, 9686, 9688, 9689, 9703, 9707, 9711, 9720, 9738, 9740, 9755, 9763, 9781, 9782, 9802, 9805, 9811, 9822, 9833, 9837, 9838, 9859, 9859, 9862, 9864, 9876, 9890, 9898, 9901, 9909, 9910, 9917, 9920, 9922, 9923, 9927, 9930, 9933, 9983, 9989, 9993, 9996, 9997, 9910, 9917, 9920, 9922, 9923, 9927, 9930, 9933, 9983, 9989, 9993, 9993, 9997, 10012, 10014, 10021, 10024, 10032, 10042, 10047, 10050, 10051, 10077, 10092, 10099, 10106, 10150, 10179, 10180, 10193, 10206, 10207, 10208, 10213, 10216, 10221, 10250, 10255, 10299, 10302, 10379, 10394, 10422, 10446, 10470, 10473, 10503, 10514, 10605, 10610, 10671, 10698, 10743, 29002, 29005, 29014, 29015, 29049, 29056, 29057, 29107, 29115, 90098, 90106, 90124, 90131, 90154, 90205, 91003, 95022, 95024, 95130, 95157, 95191, 95197, 95213, 95222, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0009-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.