FDA Device recall Z-2116-2016
Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilliance CT 64 scanner is a whole body Computed Tomography X-ray syste…
- FDA Device
- Class II
- terminated
- Published 2016-07-06
On 2016-07-06 the FDA classified a Class II recall of Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilliance CT 64 scanner is a whole body Computed Tomography X-ray syste… by Philips Medical Systems Cleveland, citing philips Healthcare received reports from the field that certain Brilliance 64 systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appe….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2116-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-01 |
| Published | 2016-07-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | US |
Product
Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilliance CT 64 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes
Reason
Philips Healthcare received reports from the field that certain Brilliance 64 systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images. A patient rescan may be required if the images cannot be used for interpretation due to the swirl-like artifact.
Identifiers
| code_info | Brilliance 64: System Code #728231 Serial numbers: 9847, 9936, 9937, 9963, 10067, 10146, 10155, 10181, 10184, 10189,…Brilliance 64: System Code #728231 Serial numbers: 9847, 9936, 9937, 9963, 10067, 10146, 10155, 10181, 10184, 10189, 10191, 10216, 10240, 10292, 10768, 10769, 10770, 10771, 10772, 10773, 10774, 10776, 10777, 10778, 10779, 10780, 10781, 10782, 10783, 10784, 10785, 10786, 10787, 10788, 10789, 10790, 10791, 10794, 10804, 10807, 29026, 29048, 29065, 29081, 29118, 29151, 91003, 95116, 95142, 95523, 95571, 95660, 95838, 95839, 95840, 95841, 95842, 95843, 95845, 95846, 95847, 95848, 95849, 95850, 95851, 95852, 95853, 95854, 95855, 95856, 95857, 95858, 95863, 95866, 95870, 95871, 95872, 95873, 95877, 95882, 95884, 95885, 95886, 95888, 95889, 95890, 95891, 95892, 95893, 95895, 95896, 95897, 95939, 6000861, 9208A, 9081 |
|---|
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-2116-2016%22
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