Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of...
Philips Healthcare (Suzhou) Co., Ltd. began a recall of Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed tomographic (CT) applications - Product... on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1273-2021
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Philips Healthcare (Suzhou) Co., Ltd.
- 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.
- Product code
- JAK System, X-Ray, Tomography, Computed
- 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.
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- On 2/18/2021, Philips issued an Urgent Medical Device Correction because the firm has detected an issue with some actuators used in the couch of Incisive CT and Access CT systems, which could result in the couch unexpectedly moving slowly downward to its limit position.
- Quantity in commerce
- 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.
- Product codes and lots
- 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
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1273-2021 | Class II | Terminated | Voluntary: Firm initiated |
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