FDA Device recall Z-0402-2018
Brilliance iCT SP - Model 728311 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 SP - Model 728311 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-0402-2018 |
| 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 SP - Model 728311 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 SP - Model 728311 Codes: 200038 200203 200119 200052 200206 200210…Brilliance iCT 4.1.6 version. Brilliance iCT SP - Model 728311 Codes: 200038 200203 200119 200052 200206 200210 200208 200213 200097 200100 200063 200009 200011 200204 200212 200018 200207 200027 200130 83001 200209 200215 200043 200032 200200 200051 200086 200202 200211 200024 200023 200068 200201 200017 200061 200205 200030 200117 200044 200015 83000 200022 200093 200101 200040 200013 200107 200111 200138 200214 200102 200047 200019 200105 200109 200121 200041 200131 200127 200003 200092 200074 200088 200067 200089 200049 |
|---|
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-0402-2018%22
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