FDA Device recall Z-1406-2018
Ingenuity Core - Model no. 728321, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cr…
- FDA Device
- Class II
- terminated
- Published 2018-04-25
On 2018-04-25 the FDA classified a Class II recall of Ingenuity Core - Model no. 728321, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cr… by Philips Medical Systems Cleveland, citing closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1406-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-08 |
| Published | 2018-04-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | US |
Product
Ingenuity Core - Model no. 728321, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Reason
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Identifiers
| code_info | Serial No. : 310204 310216 310264 52004 333094 52084 333060 333076 52069 333103 333110 333112 333064 52066…Serial No. : 310204 310216 310264 52004 333094 52084 333060 333076 52069 333103 333110 333112 333064 52066 333142 310231 333096 333149 52053 333061 333062 333136 310383 52077 333093 310219 52065 310226 333092 333107 333108 310222 310206 310207 310225 310219 310226 310238 310317 310324 310330 310365 310337 310224 333072 333067 333074 333070 52065 333086 333085 333078 333079 333156 52075 52078 333088 33084 333083 333089 52083 333099 333098 333104 333101 52079 333106 333111 52082 333113 333123 333122 333121 333118 333124 333127 333125 333141 333147 333134 333137 333139 333155 333164 52052 333097 52014 333090 333132 333159 333073 52070 333080 333081 333087 333071 333126 333120 333140 333145 333146 333150 333151 333154 333082 52012 333056 333095 333117 310209 310245 333091 333109 333115 333105 333129 333138 333144 310214 52067 310318 52068 333066 333075 333131 333133 |
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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-1406-2018%22
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