Philips Healthcare (Suzhou) Co., Ltd. Recall 87473
Description: 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.
Philips Healthcare (Suzhou) Co., Ltd. Recall 87473 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1273-2021 |
| Event ID | 87473 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | 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. |
| Quantity | 109 systems |
| Recall 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. |
| Device Classification | 20210324 |
| Device Code Info | 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 |
| Center Classification Date | 20210317 |
| Recall Initiation Date | 20210224 |
| Recalling Firm | Philips Healthcare (Suzhou) Co., Ltd. |
| Initial Notification | Letter |
| Similar To |