FDA Device recall Z-1142-2019
Brilliance 16 Air, 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by comput…
- FDA Device
- Class II
- terminated
- Published 2019-04-24
On 2019-04-24 the FDA classified a Class II recall of Brilliance 16 Air, 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by comput… by Philips Medical Systems Cleveland, citing philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. The firm has identified systems that may be….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1142-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-03 |
| Published | 2019-04-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | n/a |
Product
Brilliance 16 Air, 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories
Reason
Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. The firm has identified systems that may be at risk for this failure due to the collimator compensator being past its lifetime expected usage.
Identifiers
| code_info | 6143 5701 50069 6232 6563 50007 5928 3466 6301 6328 50048 6145 5560 6324 5908 6520 5924 5496 6507 5944 6351 6149 6562 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1142-2019%22
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