Device product
Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed tomographic (CT) applications - Product Usage: intended for use in the head and whole body.
Z-1273-2021
Product summary
- Event
- Event 87473
- Status
- Terminated
- Classification
- Class II
- Quantity
- 109 systems
- Official record key
device-enforcement:Z-1273-2021
Official wording
Reason: Philips has internally detected an issue with the actuators used in the Incisive CT couch, which could result in the couch failure to self-lock, and unexpectedly moving slowly downward to its limit position.
Code information: Unique Device Identifier (01)00884838059849(21)304034 (01)00884838059849(21)325078 (01)00884838085015(21)500218 (01)00884838085015(21)500219 (01)00884838085015(21)500221 (01)00884838085015(21)500222 (01)00884838085015(21)500223 (01)00884838085015(21)500224 (01)00884838085015(21)500225 (01)00884838085015(21)500226 (01)00884838085015(21)500227 (01)00884838085015(21)500229 (01)00884838085015(21)500231 (01)00884838085015(21)500233 (01)00884838085015(21)500234 (01)00884838085015(21)500237 (01)00884838085015(21)500238 (01)00884838085015(21)500239 (01)00884838085015(21)500241 (01)00884838085015(21)500242 (01)00884838085015(21)500245 (01)00884838085015(21)500247 (01)00884838085015(21)500248 (01)00884838085015(21)500249 (01)00884838085015(21)500251 (01)00884838085015(21)500252 (01)00884838085015(21)500254 (01)00884838085015(21)500255 (01)00884838085015(21)500256 (01)00884838085015(21)500257 (01)00884838085015(21)500258 (01)00884838085015(21)500261 (01)00884838085015(21)500264 (01)00884838085015(21)500274 (01)00884838085015(21)500283 (01)00884838085015(21)500296 (01)00884838085015(21)530038 (01)00884838085015(21)530067 (01)00884838085015(21)530071 (01)00884838085015(21)530098 (01)00884838085015(21)530099 (01)00884838085015(21)530101 (01)00884838085015(21)530103 (01)00884838085015(21)530104 (01)00884838085015(21)530106 (01)00884838085015(21)530107 (01)00884838085015(21)530108 (01)00884838085015(21)530109 (01)00884838085015(21)530111 (01)00884838085015(21)530112 (01)00884838085015(21)530113 (01)00884838085015(21)530114 (01)00884838085015(21)530115 (01)00884838085015(21)530116 (01)00884838085015(21)530117 (01)00884838085015(21)530118 (01)00884838085015(21)530119 (01)00884838085015(21)530120 (01)00884838085015(21)530121 (01)00884838085015(21)530124 (01)00884838085015(21)530126 (01)00884838085015(21)530127 (01)00884838085015(21)530128 (01)00884838085015(21)530129 (01)00884838085015(21)530130 (01)00884838085015(21)530132 (01)00884838085015(21)530133 (01)00884838085015(21)530134 (01)00884838085015(21)530135 (01)00884838085015(21)530136 (01)00884838085015(21)530137 (01)00884838085015(21)530138 (01)00884838085015(21)530141 (01)00884838085015(21)530148 (01)00884838085015(21)530150 (01)00884838085015(21)530152 (01)00884838085015(21)530156 (01)00884838085015(21)530157 (01)00884838085015(21)530159 (01)00884838085015(21)530160 (01)00884838085015(21)530163 (01)00884838085015(21)530165 (01)00884838085015(21)530166 (01)00884838085015(21)530167 (01)00884838085015(21)530169 (01)00884838085015(21)530170 (01)00884838085015(21)530171 (01)00884838085015(21)530172 (01)00884838085015(21)530173 (01)00884838085015(21)530174 (01)00884838085015(21)530175 (01)00884838085015(21)530176 (01)00884838085015(21)530177 (01)00884838085015(21)530178 (01)00884838085015(21)530180 (01)00884838085015(21)530181 (01)00884838085015(21)530182 (01)00884838085015(21)530183 (01)00884838085015(21)530186 (01)00884838085015(21)530187 (01)00884838085015(21)530188 (01)00884838085015(21)530189 (01)00884838085015(21)530190 (01)00884838085015(21)530191 (01)00884838085015(21)530192 (01)00884838085015(21)530194 (01)00884838085015(21)530197 (01)00884838085015(21)530198 (01)00884838085015(21)500230
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of KY, FL, St. Croix, and the countries of Australia, Bolivia, China, Germany, Hungary, Italy, Japan, Republic of Korea, Latvia, Palestine, Puerto Rico, Romania, Russia, Saudi Arabia, Senegal, Serbia, Spain, Sweden, Thailand, Uzbekistan.
Derived failure modes
-
Unknown
Philips has internally detected an issue with the actuators used in the Incisive CT couch, which could result in the couch failure to self-lock, and unexpectedly moving slowly downward to its limit position.