Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5....
FDA Device Recall #Z-0375-2026 — Class II — September 25, 2025
Recall Summary
| Recall Number | Z-0375-2026 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 25, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | PHILIPS MEDICAL SYSTEMS |
| Location | Cambridge, MA |
| Product Type | Devices |
| Quantity | 105 units |
Product Description
Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X;
Reason for Recall
Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation), the WED (Water Equivalent Diameter) value might set itself to zero, and this may lead to an insufficient dose setting after the surview. If operator misses the insufficient dose and the WED value in User Interface and continues with the subsequent helical/Axial scans, then the obtained images will be noisy due to low dose setting. Issue 3: Due to a software failure, the ECG wave file is not saved. As a result, the cardiac offline image reconstruction fails due to the missing ECG wave file, and the user might rescan the patient. Issue 4: This issue is software fault in which the patient orientation will be changed to NULL under specific random scenarios resulting in radiation being delivered from the wrong orientation (surview scan) or in the wrong position (clinical scan) and will generate incorrect and undiagnosable surview/clinical images. Patients may be rescanned for surview and/or clinical images. Issue 5: During scanning, the preview image display is not consistent, the images are not arriving at a fixed rate, skipping images from time to time during scanning. The obtained images might not support making the clinical diagnosis and the user might decide to re-scan the patient. Issue 6: If a user presses the left and middle/right mouse buttons together or afterwards in a short time, both commands are executed and an incorrect auto ROI is created. This ROI coordinates won t be assigned as the object is empty. As a result, the threshold of contrast level will not be reached in the UI and this will prevent the system from automatically triggering the subsequent clinical scan. There is potential safety risk identified for additionally tracker shots and/or rescan of a patient when the clinical scan is not triggered. This issue only affects the manual ROI process.
Distribution Pattern
Domestic: AL, AR, CA, CT, FL, GA, IL, IN, KY, MD, MI, OH, PA, PR, TN, TX, UT, VA; International: Argentina, Australia, Austria, Brazil, Czeck Republic, Denmark, Ecuador, Finland, France, Germany, Guyana, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Kenya, Latvia, Lebanon, Libya, Netherlands, Nicaragua, Norway, Panama, Philippines, Poland, Portugal, Reunion, Romania, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, U.A.E., Yemen;
Lot / Code Information
1. Product Code (REF): 728143; UDI-DI: 00884838085015; Serial Numbers: 500417, 500404, 500408, 500277, 500037, 500475, 500243, 500028, 500024, 510003, 33022, 500521, 500444, 500305, 500174, 500150, 500029, 500018, 500546, 500472, 510023, 510008, 500532, 500483, 500471, 500446, 500258, 500195, 500568, 33005, 2. Product Code (REF): 728144; UDI-DI: 00884838105508; Serial Numbers: 550375, 550259, 550241, 550195, 550187, 550159, 550116, 550063, 550052, 55400406111940, 550298, 550092, 550188, 5400406113211, 550467, 550328, 550177, 550136, 34318, 550300, 550296, 550248, 550234, 34252, 34224, 34217, 34176, 34157, 34147, 34142, 34108, 550605, 550580, 550129, 550103, 550056, 500509, 34499, 34458, 34405, 34136, 550040, 550447, 550041, 550359, 550350, 34546, 34188, 550686, 550065, 550059, 550025, 500506, 34237, 550474, 550141, 550115, 34401, 552001, 34529, 34408, 34532, 34516, 34280, 34259, 34251, 34223, 34208, 34179, 34174, 34159, 34137, 34082, 34080, 34003;
Other Recalls from PHILIPS MEDICAL SYSTEMS
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1825-2026 | Class II | Philips Spectral CT on Rails. Model Number: 728... | Mar 7, 2026 |
| Z-0376-2026 | Class II | Model: CT 5300; Product Code (REF): 728285; S... | Sep 25, 2025 |
| Z-0377-2026 | Class II | Model: Incisive CT for Brazil SKD; Product Cod... | Sep 25, 2025 |
| Z-1055-2024 | Class II | Spectral CT 7500: Software Version 5.0, Model 7... | Dec 13, 2023 |
| Z-1054-2024 | Class II | Spectral CT on Rails: Software Version 5.1.0.X,... | Dec 13, 2023 |
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.