FDA Device recall Z-2656-2016
Brilliance CT 16 Power, Model number 728240 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of…
- FDA Device
- Class II
- terminated
- Published 2016-08-31
On 2016-08-31 the FDA classified a Class II recall of Brilliance CT 16 Power, Model number 728240 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of… by Philips Medical Systems Cleveland, citing after upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2656-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-20 |
| Published | 2016-08-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | US |
Product
Brilliance CT 16 Power, Model number 728240 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.
Reason
After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur on gated CT helical reconstruction that is not planned at iso-center (0,0). If the region of interest is not visualized in the images, a CT rescan may be performed.
Identifiers
| code_info | 728240 -- Brilliance CT 16 Power 3100 5043 5047 5280 5345 5390 5413 5430 5495 5499 5512 6007 6009 6013 6032 6041…728240 -- Brilliance CT 16 Power 3100 5043 5047 5280 5345 5390 5413 5430 5495 5499 5512 6007 6009 6013 6032 6041 6045 6049 6051 6058 6064 6066 6070 6071 6077 6080 6081 6084 6089 6095 6100 6106 6109 6113 6115 6116 6123 6124 6131 6132 6134 6141 6144 6155 6161 6162 5476 6098 6120 6067 |
|---|
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-2656-2016%22
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