FDA Device recall Z-1874-2016
Ingenuity Core 128 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reco…
- FDA Device
- Class II
- terminated
- Published 2016-06-08
On 2016-06-08 the FDA classified a Class II recall of Ingenuity Core 128 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reco… by Philips Medical Systems Cleveland, citing the firm became aware of a problem where the system may not map Varian drive after CT user logout/login.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1874-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-08 |
| Published | 2016-06-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | US |
Product
Ingenuity Core 128 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Reason
The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.
Identifiers
| code_info | Model No. 728323; S/N: 320123 320240 30016 30023 30151 32000 32001 32008 32010 32012 32013 32015 32016 32018 32021 320…Model No. 728323; S/N: 320123 320240 30016 30023 30151 32000 32001 32008 32010 32012 32013 32015 32016 32018 32021 32024 32026 32028 32032 32033 32034 32036 32037 32041 32042 32043 32044 32046 32047 32048 32049 32050 32051 32052 32053 32054 32055 32056 32057 32058 32059 32060 32061 32062 32063 32064 32065 32067 32068 32069 32070 32071 32072 32073 32074 32075 32076 32077 32078 32079 32080 32081 32082 32084 32085 32086 32087 32088 32089 32090 32091 32092 32093 32094 32095 32096 32097 32098 32099 32100 32101 32102 32103 32104 32105 32106 32108 32109 32110 32111 32112 32113 32114 32115 32116 32117 32118 32119 32120 32121 32122 32123 32124 32125 32126 32127 32128 32129 32130 32131 32132 32133 32134 32135 32136 32137 32138 32139 32140 32141 32142 32143 32144 32145 32146 32147 32148 32149 32150 32151 32152 32153 32154 32155 32156 32157 32158 32159 32160 32161 32162 32163 32164 32165 32166 32167 32168 52023 52028 52049 52062 122928 320001 320002 320003 320005 320006 320008 320010 |
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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-1874-2016%22
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