FDA Device recall Z-2653-2016
Brilliance CT Big Bore Oncology, Model number 728243 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional i…
- FDA Device
- Class II
- terminated
- Published 2016-08-31
On 2016-08-31 the FDA classified a Class II recall of Brilliance CT Big Bore Oncology, Model number 728243 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional i… 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-2653-2016 |
| 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 Big Bore Oncology, Model number 728243 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 | 728243 Brilliance BigBore Oncology CT 7116 7611 7354 7063 7309 7169 7205 7016 7019 7043 7069 7073 7091 7112 7…728243 Brilliance BigBore Oncology CT 7116 7611 7354 7063 7309 7169 7205 7016 7019 7043 7069 7073 7091 7112 7132 7163 7141 7194 7226 7325 7294 7350 7316 7480 7114 7210 7310 7438 7530 7186 7119 7042 |
|---|
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-2653-2016%22
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