Philips recalls specific Incisive CT models with software versions 5.1.0.X and 5.1.1.X due to potential incorrect scans, patient rescans, and image quality issues. Affected units may require software updates to prevent safety risks.
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.
Philips is recalling certain Incisive CT scanners with software versions 5.1.0.X and 5.1.1.X. These models may produce incorrect scans, cause patients to be rescanned, or fail to save cardiac data, which could lead to misdiagnosis or unnecessary repeat scans.
The software issues can cause the CT scanner to produce incorrect images, skip scans, or fail to save critical cardiac data. This may result in misdiagnosis, unnecessary patient rescans, or radiation exposure from improper positioning.
Healthcare facilities using Philips Incisive CT scanners with product codes 728143 or 728144 and software versions 5.1.0.X or 5.1.1.X are most at risk. Patients undergoing scans with these units may face incorrect results or repeated imaging.
Check for product codes 728143 or 728144, software versions 5.1.0.X or 5.1.1.X, and serial numbers listed in the recall notice. The affected units are identified by specific serial numbers provided in the recall documentation.
Verify the software version on your scanner to see if it is 5.1.0.X or 5.1.1.X.
Reach out to Philips for guidance on software updates or other remedies if your unit is affected.
Philips identified software issues that could cause incorrect scans, patient rescans, or missing cardiac data, potentially leading to misdiagnosis or unnecessary repeat imaging.
No. The recall requires checking the software version and contacting Philips for updates, not immediate discontinuation.
Affected units may produce incorrect images, require rescans, or fail to save cardiac data, which could lead to misdiagnosis or additional radiation exposure.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-0375-2026 — Philips Philips Hello, I own a Philips that is covered by recall Z-0375-2026 from Philips. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
