FDA Device recall Z-0519-2018
Philips Ingenuity Core 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 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-0519-2018 |
| 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 computed tomography x-ray system
Reason
Numerous issues related to software Brilliance iCT 4.1.6 software version.
Identifiers
| code_info | Ingenuity Core 728321 SN# - 310003 310002 310001 310096 310023 310017 310022 310071 310105 310026 310032 31…Ingenuity Core 728321 SN# - 310003 310002 310001 310096 310023 310017 310022 310071 310105 310026 310032 310042 310039 310064 310059 310052 333002 310055 310069 310070 310088 310087 310111 310090 310116 310107 310009 310121 310081 333009 310113 310119 333015 310129 52013 333005 333080 333064 52015 310133 310134 310143 310141 310159 310135 310151 333041 310157 310149 333030 310170 333019 310160 30041 52012 333014 52022 333031 52008 310203 52000 333018 333061 52010 310204 333021 52007 333076 52014 52018 52019 52021 333093 333052 52045 52040 52026 333045 52024 52020 333044 52032 333051 52033 52038 52041 333037 333042 52042 310211 333117 333043 52039 333056 310234 310212 310214 333053 31001 333055 52030 310207 52043 52052 310205 52031 52047 333046 52061 52059 333066 52057 333060 333059 52053 333062 52058 52055 52054 52025 310215 52029 52037 52034 52035 52036 52046 |
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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-0519-2018%22
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