FDA Device recall Z-1507-2024
PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to V4.5.1.41989-Intended to produce cross-…
- FDA Device
- Class II
- ongoing
- Published 2024-04-17
On 2024-04-17 the FDA classified a Class II recall of PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to V4.5.1.41989-Intended to produce cross-… by Philips North America, citing patient tabletop moved out to the home position during scan initialization, may cause operator/bystander staying by the rear of the table to collide with the moved tabletop and be….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1507-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-12-24 |
| Published | 2024-04-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips North America |
| Distribution | US |
Product
PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to V4.5.1.41989-Intended to produce cross-sectional images of the body Model Number: 728143
Reason
Patient tabletop moved out to the home position during scan initialization, may cause operator/bystander staying by the rear of the table to collide with the moved tabletop and be injured
Identifiers
| code_info | UDI-DI: (01)00884838085015(21) Serial Numbers: 500092 500202 500264 500265 33002 500217 500046 33001 33003 500064 50010…UDI-DI: (01)00884838085015(21) Serial Numbers: 500092 500202 500264 500265 33002 500217 500046 33001 33003 500064 500102 500110 500111 500145 500168 500178 500211 500216 500222 500242 500252 500255 500282 500032 500073 500138 500034 500038 500069 500091 500135 500087 500041 500056 500089 500103 500105 500116 500123 500125 500136 500152 500200 500213 500219 500233 500256 500045 500024 500028 500122 500173 500283 500003 500020 500052 500075 500118 500134 500146 500149 500150 500218 500223 500232 500210 500225 500049 500067 500076 500081 500249 500129 500141 500142 500143 500144 500155 500156 500160 500161 500175 500181 500182 500185 500186 500187 500190 500191 500201 500204 500220 500221 500228 500235 500237 500250 500262 500266 500267 500268 500272 500275 500278 500284 500179 500195 500258 500031 500159 500074 500230 500240 500002 500035 500040 500158 500097 500043 500263 500205 500184 500274 500203 500128 500259 500080 500126 500206 500207 500171 500183 500188 500194 500059 500245 5002 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1507-2024%22
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