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

    • 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
  • 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 9, 2023 · Data as of Sep 19, 5:41 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.