FDA Device recall Z-1407-2018
Ingenuity Core 128 - Model no. 728323, 728324, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended t…
- FDA Device
- Class II
- terminated
- Published 2018-04-25
On 2018-04-25 the FDA classified a Class II recall of Ingenuity Core 128 - Model no. 728323, 728324, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended t… 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-1407-2018 |
| 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 128 - Model no. 728323, 728324, 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: 320309 336076 32104 336092 336150 336100 336228 336089 336095 336100 336116 32125 32123 336117…Serial no: 320309 336076 32104 336092 336150 336100 336228 336089 336095 336100 336116 32125 32123 336117 336120 336126 336139 336131 336149 336142 336150 336152 336161 336166 336150 336182 336203 336211 336217 336220 336221 336289 336283 336133 336145 336191 30035 345218 52073 336213 320227 320419 336188 32106 336123 336216 32117 32119 32151 66769829 320265 32144 32150 32160 32157 32159 32127 320363 32145 32129 32141 32133 32127 32168 336737 336760 336764 336766 336807 336809 320260 320268 320270 320271 320253 320276 320280 320285 320289 320291 320292 320318 320294 320316 320259 320279 320286 320326 320293 320327 320296 320290 320306 320321 320307 320311 320319 320315 320366 320390 320379 320371 320386 320323 320325 320340 320334 320329 320331 320391 320359 320384 320343 320365 320403 320374 320380 320393 320420 336800 32108 32096 32122 336802 32115 336803 3211 |
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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-1407-2018%22
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