Incisive CT Computed Tomography X-ray System Model: 728143
FDA Device Recall #Z-1265-2021 — Class II — February 22, 2021
Recall Summary
| Recall Number | Z-1265-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 22, 2021 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips North America Llc |
| Location | Cambridge, MA |
| Product Type | Devices |
| Quantity | 105 units (1 US and 104 OUS) |
Product Description
Incisive CT Computed Tomography X-ray System Model: 728143
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
Distribution Pattern
US Virgin Island Foreign: Australia Bolivia China Germany Hungary Indonesia Italy Japan Korea Korea, Republic of Latvia Palestine Philippines Romania Russian Federation Senegal Thailand Uzbekistan
Lot / Code Information
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
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| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1316-2026 | Class II | IQon Spectral CT; Product Code (REF): 728332; | Jan 7, 2026 |
| Z-1318-2026 | Class II | Spectral CT 7500 on Rails; Product Code (REF):... | Jan 7, 2026 |
| Z-1317-2026 | Class II | Spectral CT; Product Code (REF): 728333; | Jan 7, 2026 |
| Z-1315-2026 | Class II | Brilliance iCT; Product Code (REF): 728306; | Jan 7, 2026 |
| Z-1033-2026 | Class II | Philips Smart-hopping 2.0 AP 1.4 GHz. Patient M... | Dec 12, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.