Z-1273-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 24, 2021
- Initiation Date
- February 24, 2021
- Termination Date
- February 17, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 109 systems
Product 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.
Reason for Recall
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.
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.
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