Reported Mar 24, 2021 · Terminated
Incisive CT Computed Tomography X-ray System Model: 728143
Philips North America LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America Llc · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
- Incisive CT
- Computed Tomography X-ray System Model728143
- Lot codes and dates
- Serial NumbersUS: 500230
- OUS
104 of 104 codes
500246500260500277500261530004530102530101530103530107530109530108530113530110530119530118530117530120530125530121530124530128530126530127530129530130530132530133530134530135530136530137530139530141530138530140530144530143530145530148530146530142530147530149530154530151530158530150530153530152530157530156530159530165530161530160530162530164530163530166530171
- 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
- Amount recalled
- 105 units (1 US and 104 OUS)
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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