FDA Device recall Z-0840-2018
Brilliance Big Bore Oncology CTwith 4.2.0 software version
- FDA Device
- Class II
- terminated
- Published 2018-03-14
On 2018-03-14 the FDA classified a Class II recall of Brilliance Big Bore Oncology CTwith 4.2.0 software version by Philips Medical Systems Cleveland, citing software issues including: Software errors that may result in Extended Field of View check message not displayed when Field of View is set >600 mm for a paused scan; Request for c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0840-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-03 |
| Published | 2018-03-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | US |
Product
Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 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. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Reason
Software issues including: Software errors that may result in Extended Field of View check message not displayed when Field of View is set >600 mm for a paused scan; Request for change to automatically turn on the center x/y 0 setting and the disable result rotation setting when turning on the CT simulation Exam Card; Software errors that may result in Tumor LOC allowing POI (Point of Interest) locking when a non-isocenter slice is displayed; Software errors that may result in partial set of images or inability to generate CT images.
Identifiers
| code_info | Brilliance Big Bore Oncology CT, Model # 728243 Serial #s: 76025 76022 76024 76023 76016 76021 76008 76010 76002 76020 76011 |
|---|
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-0840-2018%22
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