FDA Device recall Z-1396-2018
Brilliance 64 with 4.1.7 XX026 software version model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce cr…
- FDA Device
- Class II
- terminated
- Published 2018-04-25
On 2018-04-25 the FDA classified a Class II recall of Brilliance 64 with 4.1.7 XX026 software version model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce cr… by Philips Medical Systems Cleveland, citing surview scan with tube current lower than 30 mA is unable to be initialized.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1396-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-21 |
| Published | 2018-04-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | US |
Product
Brilliance 64 with 4.1.7 XX026 software version model number 728231 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 analysis and display equipment, patient and equipment supports, components, and accessories
Reason
Surview scan with tube current lower than 30 mA is unable to be initialized.
Identifiers
| code_info | Serial numbers: . 9134 9667 9738 9788 9923 10773 95263 95669 |
|---|
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-1396-2018%22
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