Incisive CT Computed Tomography X-ray System Model: 728143

Class I - Dangerous

🏥 Medical Devices Recalled: February 22, 2021 Philips North America Infusion Pumps

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Serial Numbers: US: 500230 OUS: 500246 500260 500277 500261 530004 530102 530101 530103 530107 530109 530108 530113 530110 530119 530118 530117 530120 530125 530121 530124 530128 530126 530127 530129 530130 530132 530133 530134 530135 530136 530137 530139 530141 530138 530140 530144 530143 530145 530148 530146 530142 530147 530149 530154 530151 530158 530150 530153 530152 530157 530156 530159 530165 530161 530160 530162 530164 530163 530166 530171 530167 530168 530170 530169 530174 530173 530176 530185 530179 530172 530177 530196 530200 530201 530211 530212 530219 530221 500048 500231 500244 500247 500254 500257 500273 500270 500269 500226 500227 500241 500276 500229 500245 500248 500274 500263 500258 500278 500286 500225 500233 500256 500264 500265 UDI: (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)530107 (01)00884838085015(21)530108 (01)00884838085015(21)530109 (01)00884838085015(21)530113 (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)530125 (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)530139 (01)00884838085015(21)530140 (01)00884838085015(21)530141 (01)00884838085015(21)530142 (01)00884838085015(21)530143 (01)00884838085015(21)530144 (01)00884838085015(21)530145 (01)00884838085015(21)530146 (01)00884838085015(21)530147 (01)00884838085015(21)530148 (01)00884838085015(21)530149 (01)00884838085015(21)530150 (01)00884838085015(21)530151 (01)00884838085015(21)530152 (01)00884838085015(21)530153 (01)00884838085015(21)530154 (01)00884838085015(21)530156 (01)00884838085015(21)530157 (01)00884838085015(21)530158 (01)00884838085015(21)530159 (01)00884838085015(21)530160 (01)00884838085015(21)530161 (01)00884838085015(21)530162 (01)00884838085015(21)530163 (01)00884838085015(21)530164 (01)00884838085015(21)530165 (01)00884838085015(21)530166 (01)00884838085015(21)530167 (01)00884838085015(21)530168 (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)530176 (01)00884838085015(21)530177 (01)00884838085015(21)530179 (01)00884838085015(21)530180 (01)00884838085015(21)530185 (01)00884838085015(21)530196 (01)00884838085015(21)530200 (01)00884838085015(21)530211 (01)00884838085015(21)530219 (01)00884838085015(21)530221
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Philips North America Llc
Reason for Recall:: Actuators in the Incisive gantry could result in the gantry failure to self-lock if both of the 2 sides actuators fail. In some cases in systems with affected components, the gantry may tilt forward slowly, in a worst case, reaching to the tilt limit angle +31degrees
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

Incisive CT Computed Tomography X-ray System Model: 728143

Product Codes/Lot Numbers:

Serial Numbers: US: 500230 OUS: 500246 500260 500277 500261 530004 530102 530101 530103 530107 530109 530108 530113 530110 530119 530118 530117 530120 530125 530121 530124 530128 530126 530127 530129 530130 530132 530133 530134 530135 530136 530137 530139 530141 530138 530140 530144 530143 530145 530148 530146 530142 530147 530149 530154 530151 530158 530150 530153 530152 530157 530156 530159 530165 530161 530160 530162 530164 530163 530166 530171 530167 530168 530170 530169 530174 530173 530176 530185 530179 530172 530177 530196 530200 530201 530211 530212 530219 530221 500048 500231 500244 500247 500254 500257 500273 500270 500269 500226 500227 500241 500276 500229 500245 500248 500274 500263 500258 500278 500286 500225 500233 500256 500264 500265 UDI: (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)530107 (01)00884838085015(21)530108 (01)00884838085015(21)530109 (01)00884838085015(21)530113 (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)530125 (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)530139 (01)00884838085015(21)530140 (01)00884838085015(21)530141 (01)00884838085015(21)530142 (01)00884838085015(21)530143 (01)00884838085015(21)530144 (01)00884838085015(21)530145 (01)00884838085015(21)530146 (01)00884838085015(21)530147 (01)00884838085015(21)530148 (01)00884838085015(21)530149 (01)00884838085015(21)530150 (01)00884838085015(21)530151 (01)00884838085015(21)530152 (01)00884838085015(21)530153 (01)00884838085015(21)530154 (01)00884838085015(21)530156 (01)00884838085015(21)530157 (01)00884838085015(21)530158 (01)00884838085015(21)530159 (01)00884838085015(21)530160 (01)00884838085015(21)530161 (01)00884838085015(21)530162 (01)00884838085015(21)530163 (01)00884838085015(21)530164 (01)00884838085015(21)530165 (01)00884838085015(21)530166 (01)00884838085015(21)530167 (01)00884838085015(21)530168 (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)530176 (01)00884838085015(21)530177 (01)00884838085015(21)530179 (01)00884838085015(21)530180 (01)00884838085015(21)530185 (01)00884838085015(21)530196 (01)00884838085015(21)530200 (01)00884838085015(21)530211 (01)00884838085015(21)530219 (01)00884838085015(21)530221

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1265-2021

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