FDA Device recall Z-0546-2016
Brilliance iCT SP Computed Tomography X-ray system
- FDA Device
- Class II
- terminated
- Published 2015-12-30
On 2015-12-30 the FDA classified a Class II recall of Brilliance iCT SP Computed Tomography X-ray system by Philips Medical Systems Cleveland, citing perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0546-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-29 |
| Published | 2015-12-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | US |
Product
Brilliance iCT SP Computed Tomography X-ray system
Reason
Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2.
Identifiers
| code_info | Model No. 728311; S/N: 200047, 200051, 200067, 200074, 200098, 200127, 200200, 200202, 200203, 200204, 200206 & 200209. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0546-2016%22
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