FDA Device recall Z-1405-2018
Ingenuity CT - Model no. 728326, 728325, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to prod…
- FDA Device
- Class II
- terminated
- Published 2018-04-25
On 2018-04-25 the FDA classified a Class II recall of Ingenuity CT - Model no. 728326, 728325, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to prod… 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-1405-2018 |
| 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 CT - Model no. 728326, 728325, 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. : 32045 52062 30003 30004 300225 30029 30007 300220 300211 300229 300243 300209 30027 30041 30…Serial No. : 32045 52062 30003 30004 300225 30029 30007 300220 300211 300229 300243 300209 30027 30041 30040 300247 300233 300237 300236 30038 300222 300227 300234 30038 30037 30039 30048 300240 30046 30044 30036 300215 300201 300200 336121 300202 300228 300248 30011 300214 300217 300216 300224 300242 300245 300231 300230 300226 300239 300241 30028 30042 30018 30019 30018 300238 30030 336084 333057 30043 30033 30033 30026 32109 32102 30045 300221 30017 52060 30034 30049 30047 320392 320383 310328 310313 300204 300207 300205 300203 300150 300212 300213 300206 320205 300208 300210 300219 300086 300235 300223 300232 310314 310377 336286 320247 310362 310375 338003 320434 320388 320385 320322 320396 320368 320338 320364 320346 320369 320400 320437 336147 320214 320235 320378 320297 320337 320395 310353 320339 320402 320397 310379 310370 32128 320353 320405 320401 |
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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-1405-2018%22
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