Philips CT systems are advanced continuous-rotation recall
Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed tomographic (CT) applications…
Why was Philips CT systems are advanced continuous-rotation recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed tomographic (CT) applications…
- Recalling firm
- Philips Healthcare (Suzhou) Co., Ltd.
- Quantity
- 109 systems
- 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.
- Recall date
- March 24, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)