Ingenuity Core Computed Tomography X-ray Systems, Product Usage: Intended to produce cross...
FDA Device Recall #Z-1873-2016 — Class II — April 8, 2016
Recall Summary
| Recall Number | Z-1873-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 8, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips Medical Systems (Cleveland) Inc |
| Location | Cleveland, OH |
| Product Type | Devices |
| Quantity | 300 Units |
Product Description
Ingenuity Core Computed Tomography X-ray Systems, Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Reason for Recall
The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also shipped to the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, Colombia, Cuba, Estonia, Finland, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.
Lot / Code Information
Model No. 728321; S/N: 310135 310257 52035 333068 31001 33084 52000 52007 52008 52010 52012 52013 52014 52015 52018 52019 52020 52021 52022 52024 52025 52026 52027 52029 52030 52031 52032 52033 52034 52036 52037 52038 52039 52040 52041 52042 52043 52044 52045 52046 52047 52048 52050 52052 52053 52054 52055 52056 52057 52058 52059 52061 52063 52064 52065 52066 52067 52068 52069 52070 52071 52072 52075 52076 52077 52078 52079 52080 52081 132164 132465 300141 310001 310002 310003 310009 310017 310022 310023 310026 310032 310039 310042 310052 310054 310055 310059 310064 310069 310070 310071 310081 310087 310088 310090 310096 310098 310107 310111 310113 310119 310121 310129 310133 310134 310141 310143 310149 310151 310157 310159 310160 310170 310203 310204 310205 310206 310207 310208 310209 310210 310211 310212 310213 310214 310215 310216 310217 310218 310219 310220 310221 310222 310223 310224 310225 310226 310227 310228 310229 310230 310231 310232 310233 310234 310235 310236 310237 310238 310239 310240 310241 310242 310243 310245 310246 310247 310248 310249 310250 310252 310253 310254 310255 310256 310258 310259 310260 310261 310262 310263 310264 310265 310266 310267 310269 310270 310271 310272 310273 310274 310275 310276 310277 310278 310279 310280 310281 310282 310283 310284 310285 310286 310287 310288 310289 310290 310291 310292 310293 310294 310295 310296 310297 310299 310300 310301 310304 310308 333002 333004 333005 333009 333010 333014 333015 333018 333019 333021 333030 333031 333037 333042 333043 333044 333045 333046 333048 333049 333050 333051 333052 333053 333054 333055 333056 333059 333060 333061 333062 333063 333064 333065 333066 333067 333069 333070 333071 333072 333073 333074 333075 333076 333077 333078 333079 333080 333081 333082 333083 333085 333086 333087 333088 333089 333090 333091 333092 333093 333094 333095 333096 333097 333098 333099 333100 333101 333102 333103 333104 333105 333106 333107 333108 333109 333110 333111 333112 333113 333114 333115 333116 333117 333118 333119 333120 333121 333122 333123 333124.
Other Recalls from Philips Medical Systems (Cleveland) Inc
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|---|---|---|---|
| Z-2570-2025 | Class II | Pinnacle Radiation Therapy Planning System: ... | Aug 5, 2025 |
| 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
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.