Ingenuity CT - Model no. 728326, 728325, Computed Tomography X-Ray system Product Usage: Comp...
FDA Device Recall #Z-1405-2018 — Class II — February 8, 2018
Recall Summary
| Recall Number | Z-1405-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 8, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips Medical Systems (Cleveland) Inc |
| Location | Cleveland, OH |
| Product Type | Devices |
| Quantity | 172 |
Product Description
Ingenuity CT - Model no. 728326, 728325, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Reason for Recall
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Distribution Pattern
Worldwide Distribution - U.S. Nationwide. International distribution to Canada, Mexico, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djibouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guyana, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Laos, Lebanon, Lithuania, Macedonia, Malaysia, Maldives, Mali, Martinique, Monaco, Mongolia, Myanmar, Nepal, Netherlands, New Calcedonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saint Pierre and Miquelon, Samoa, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, and Vietnam.
Lot / Code Information
Serial No. : 32045 52062 30003 30004 300225 30029 30007 300220 300211 300229 300243 300209 30027 30041 30040 300247 300233 300237 300236 30038 300222 300227 300234 30038 30037 30039 30048 300240 30046 30044 30036 300215 300201 300200 336121 300202 300228 300248 30011 300214 300217 300216 300224 300242 300245 300231 300230 300226 300239 300241 30028 30042 30018 30019 30018 300238 30030 336084 333057 30043 30033 30033 30026 32109 32102 30045 300221 30017 52060 30034 30049 30047 320392 320383 310328 310313 300204 300207 300205 300203 300150 300212 300213 300206 320205 300208 300210 300219 300086 300235 300223 300232 310314 310377 336286 320247 310362 310375 338003 320434 320388 320385 320322 320396 320368 320338 320364 320346 320369 320400 320437 336147 320214 320235 320378 320297 320337 320395 310353 320339 320402 320397 310379 310370 32128 320353 320405 320401 320375 310387 310326 310340 310339 320404 310356 320382 310342 310341 320406 320409 310360 310357 310349 320426 310135 310211 310302 310328 310351 320349 310358 310352 310355 310348 310381 320389 310369 310361 310313 320372 320347 320328 320341 310333 320298 310354 320324 320354 320361 310359 333181 300218
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.