Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
FDA Device Recall #Z-0640-2024 - Class II, December 23, 2022
Recall Summary
| Recall Number | Z-0640-2024 |
| Classification | Class II - Moderate risk |
| Date Initiated | December 23, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips Healthcare (Suzhou) Co., Ltd. |
| Location | Suzhou |
| Product Type | Devices |
| Quantity | 828 |
Product Description
Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
Reason for Recall
Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orientation labels, or the need for a CT rescan. These include: 1. Artifacts may occur on perfusion images, 2. Orientation label reversed in 2D images, 3. Auto voice does not work during the cardiac scan, 4. Auto voice and operators voice are too quiet, patient cant hear, 5. Not all of the images are reconstructed in some cases, 6. No image displayed on the console monitor after enabling CCT Single Scan, 7. Ring artifact appears in 32x0.625 collimation of bone scan when soft tissue view is selected, 8. A design defect where the error couch motion signal of couch firmware causes couch to identify current position as target position in next protocol, and 9. calcium scoring study split into separate series after loading to ISP.
Distribution Pattern
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MD, ME, MI, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, PA, RI, SC, TN, TX, UT, VT, WI, & Puerto Rico and the countries of Albania, Algeria, Argentina, Australia, Austria, Bhutan, Bolivia, Bosnia-Herz, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Ethiopia, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Laos, Latvia, Lebanon, Lithuania, Malaysia, Mali, Mauritius, Moldova, Morocco, Netherlands, New Zealand, Norway, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Rwanda, Saint Kitts, Saint Lucia, Saudi Arabia, Senegal, Serbia, Sint Maarten, Slovakia, South Africa, South Korea, Spain, St. Pier Miquel, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, United Arab Emirates, Uzbekistan, Venezuela, & Vietnam.
Lot / Code Information
UDI-DI: 00884838085015 (Model 728143) UDI-DI: 00884838105508 (Model 728144)
Other Recalls from Philips Healthcare (Suzhou) Co., Ltd.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2988-2026 | Class II | Philips Incisive CT with software V4.5&V5.0, Pr... | Jun 26, 2026 |
| Z-1003-2026 | Class II | Philips Incisive CT | Dec 3, 2025 |
| Z-1273-2021 | Class II | Philips CT systems are advanced continuous-rota... | Feb 24, 2021 |
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.