FDA Device recall Z-0403-2018
Brilliance iCT - Model 728306 Computed Tomography X-ray systems
- FDA Device
- Class II
- terminated
- Published 2018-01-31
On 2018-01-31 the FDA classified a Class II recall of Brilliance iCT - Model 728306 Computed Tomography X-ray systems by Philips Medical Systems Cleveland, citing numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error m….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0403-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-11 |
| Published | 2018-01-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | US |
Product
Brilliance iCT - Model 728306 Computed Tomography X-ray systems
Reason
Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image volume and other functions.
Identifiers
| code_info | Brilliance iCT 4.1.6 version. Brilliance iCT - Model 728306 Codes: 100688 85025 100790 100490 100667 85054 100…Brilliance iCT 4.1.6 version. Brilliance iCT - Model 728306 Codes: 100688 85025 100790 100490 100667 85054 100408 100604 85031 100703 100411 100114 100314 100278 100349 100654 100406 100452 100453 100404 100242 100115 100383 100189 100347 100348 100450 100748 100507 100181 100469 200005 100638 100195 100101 100440 100223 100616 100619 100134 100304 100656 100436 100773 100130 100621 100113 85055 100600 100180 85060 100704 100750 85041 100737 100231 100615 100612 100393 100643 100356 100134 100722 85048 85059 100680 85016 100521 100678 100726 85052 100683 100760 100691 100635 100738 85057 100614 100758 100687 100138 100733 100707 100706 100701 100191 85062 100247 100318 85002 85023 100712 85058 85026 85037 85027 100310 85068 100512 100734 85051 100161 100628 100740 85035 100709 100775 100669 100769 100768 100800 100792 100637 100692 100639 100735 100756 100776 85069 |
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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-0403-2018%22
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