FDA Device recall Z-0520-2018
Philips Ingenuity Core 128 computed tomography x-ray system
- FDA Device
- Class II
- terminated
- Published 2018-02-14
On 2018-02-14 the FDA classified a Class II recall of Philips Ingenuity Core 128 computed tomography x-ray system by Philips Medical Systems Cleveland, citing numerous issues related to software Brilliance iCT 4.1.6 software version.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0520-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-06 |
| Published | 2018-02-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | n/a |
Product
Philips Ingenuity Core 128 computed tomography x-ray system
Reason
Numerous issues related to software Brilliance iCT 4.1.6 software version.
Identifiers
| code_info | Ingenuity Core 128 - 728323 SN# - 320002 320001 320006 320003 320005 320010 320008 320030 320037 320019 32…Ingenuity Core 128 - 728323 SN# - 320002 320001 320006 320003 320005 320010 320008 320030 320037 320019 320033 320018 320024 320029 320026 320031 320059 320054 320058 320074 320081 336207 320079 320078 320069 320080 320073 320115 320092 320090 320083 320084 320082 320096 320133 320103 320100 320101 336015 320138 32021 320107 320111 320132 320126 320114 336016 320248 320123 336011 320099 320122 336018 320134 320215 320146 320119 336013 320125 320131 32058 32013 320129 32085 320147 336012 320128 336017 336025 32042 336023 32012 320206 336034 320144 32018 336029 32016 336028 320227 32026 32032 32099 320214 32015 32054 336046 336070 32024 336027 32010 336103 32059 336069 32055 336040 32033 320204 32037 32043 32047 32034 32036 32049 32041 336072 336075 336044 32044 32070 32069 32050 32091 32089 32092 32072 32048 336067 32052 32102 32062 32046 32074 32056 32073 3360 |
|---|
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-0520-2018%22
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