Philips Ingenuity Core computed tomography x-ray system
FDA Device Recall #Z-0519-2018 — Class II — October 6, 2017
Recall Summary
| Recall Number | Z-0519-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 6, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips Medical Systems (Cleveland) Inc |
| Location | Cleveland, OH |
| Product Type | Devices |
| Quantity | N/A |
Product Description
Philips Ingenuity Core computed tomography x-ray system
Reason for Recall
Numerous issues related to software Brilliance iCT 4.1.6 software version.
Distribution Pattern
26 US Govt accounts
Lot / Code Information
Ingenuity Core 728321 SN# - 310003 310002 310001 310096 310023 310017 310022 310071 310105 310026 310032 310042 310039 310064 310059 310052 333002 310055 310069 310070 310088 310087 310111 310090 310116 310107 310009 310121 310081 333009 310113 310119 333015 310129 52013 333005 333080 333064 52015 310133 310134 310143 310141 310159 310135 310151 333041 310157 310149 333030 310170 333019 310160 30041 52012 333014 52022 333031 52008 310203 52000 333018 333061 52010 310204 333021 52007 333076 52014 52018 52019 52021 333093 333052 52045 52040 52026 333045 52024 52020 333044 52032 333051 52033 52038 52041 333037 333042 52042 310211 333117 333043 52039 333056 310234 310212 310214 333053 31001 333055 52030 310207 52043 52052 310205 52031 52047 333046 52061 52059 333066 52057 333060 333059 52053 333062 52058 52055 52054 52025 310215 52029 52037 52034 52035 52036 52046 333054 333072 310223 333065 333075 52056 52027 333067 310220 310206 310236 310208 52048 333085 333073 333101 52069 333049 52064 333069 333087 52044 52065 333078 52079 333070 310210 52072 333074 52067 52068 333088 52075 310213 333063 333048 333050 52063 310292 52071 333068 310227 310217 333077 333086 333145 310209 333091 333082 333096 33084 333110 52070 310228 310241 52078 333116 333081 333094 310243 310232 310288 52076 310281 310254 310230 333090 333079 310226 310219 310225 310224 310221 52050 310216 310252 333083 52077 310238 310222 310294 310249 310229 333121 310250 310275 333112 310247 333097 310218 310257 310296 310304 310235 310255 310237 310246 310240 333071 310286 310248 310260 333089 52081 333095 333099 333098 310233 310231 310259 310283 310295 310239 310279 310276 310289 333114 310245 310291 310258 310293 310284 333109 333115 310297 310256 310308 310270 310264 333103 333136 310242 310287 310316 310273 310262 310253 310282 310271 310299 310274 310265 310311 310280 310269 333100 310277 310272 310261 310267 333105 310263 310278 310300 333119 310285 310266 310290 333102 333125 310301 333135 333092 333104 333106 333108 333107 333113 310315 333134 310318 310303 333129 333133 333118 333122 333124 333123 333111 310320 310313 52004 52074 310150 310312 310341 310342 310343 333128 310350 333163 310358 310351 310357 310359 333164 310360 310361 310125 310098 310384 333177 310382 333174 333176 310383 310373 333173 333178 333175 52086 52085 310381 310379 310385 333166 52087 333179 333181 333180 310386 52088 132164 132465
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| Z-2239-2025 | Class II | Pinnacle 3 with TumorLOC, (870258) Radiation Th... | Jul 17, 2025 |
| Z-1744-2022 | Class II | Pinnacle3 Radiation Therapy Planning System, Mo... | Aug 30, 2022 |
| Z-0213-2020 | Class I | Forte Gamma Camera System is intended to produc... | Sep 19, 2019 |
| Z-0217-2020 | Class I | Forte Gamma Camera System is intended to produc... | Sep 19, 2019 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
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.