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
Check against the official notice below — it lists the full affected range.
Philips is recalling 428 Incisive CT systems nationwide and in multiple countries worldwide due to a software issue where the patient tabletop moves to its home position during scan initialization. This unexpected movement can cause operators or bystanders standing near the rear of the table to be struck by the tabletop and sustain injuries.
The affected units are identified by specific serial numbers ranging from 500001 to 500284, with a UDI-DI code of (01)00884838085015(21). The recall affects systems that were upgraded from software version V4.5.1.41921 to V4.5.1.41989. The source document does not specify what remedy affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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
Reason for recall: 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 Distribution: Nationwide including Puerto Rico Foreign: Albania Argentina Australia Austria Bangladesh Bolivia Brazil Bulgaria China Czech Republic Denmark Ecuador Egypt France Germany Greece Hungary India Indonesia Iraq Italy Japan Jordan Kazakhstan Kenya Korea, Republic of Kuwait Latvia Lebanon Libya Malaysia Myanmar Nepal Netherlands Norway Pakistan Palestine, State of Peru Philippines Poland Puerto Rico Qat Quantity: 428 units Lot/code info: 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 500248 500051 500189 500078 500153 500157 500229 500276 500199 500176 500177 500196 500047 500010 500036 500044 500079 500096 500106 500212 500226 500227 500241 500099 500060 500071 500082 500113 500120 500121 500124 500163 500215 500247 500251 500253 500254 500257 500269 500270 500271 500273 500279 500083 500132 500108 500164 500244 500001 500004 500011 500012 500013 500014 500017 500039 500054 500055 500058 500090 500127 500131 500197 500139 500154 500162 500231 500066 500048 500026 500062 500068
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.