Model: Incisive CT — Class II medical device recall Z-0375-2026
Ongoing recall by PHILIPS MEDICAL SYSTEMS, reported 2025-11-05, distributed in AL, AR, CA, CT, FL, GA, IL, IN…. Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used
| Recall number | Z-0375-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PHILIPS MEDICAL SYSTEMS, Cambridge, MA, United States |
| Recall initiated | 2025-09-25 |
| Classified | 2025-10-27 |
| Reported by FDA | 2025-11-05 |
| Distributed | AL, AR, CA, CT, FL, GA, IL, IN, KY, MD, MI, OH, PA, PR, TN, TX, UT, VA |
| Countries outside the US | AE, AR, AT, AU, BR, CH, DE, DK, EC, ES, FI, FR, GB, GY, HK, HU, ID, IE, IL, IN, IQ, IR, IT, JP, KE, KR, LB, LV, NI, NL, NO, PA, PH, PL, PT, RO, SE, TH, TR, TW, ZA |
| Quantity | 105 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00884838085015, 00884838105508, 55400406111940 |
| Serial numbers | 33005, 33022, 34003, 34080, 34082, 34108, 34136, 34137, 34142, 34147, 34157, 34159, 34174, 34176, 34179, 34188, 34208, 34217, 34223, 34224, 34237, 34251, 34252, 34259, 34280 and 80 more |
| Model numbers | 00884838085015, 00884838105508, 728143, 728144 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0375-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.