Philips Medical Systems recalls Incisive CT software versions 5.1.0.X and 5.1.1.X for Brazil SKD models. Issues may cause incorrect scans, rescans, or missing ECG data. Affected units must be updated by software fix.
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 Medical Systems is recalling Incisive CT scanners sold in Brazil with specific software versions due to multiple software issues that could lead to incorrect scans, rescans, or missing ECG data. These problems may cause patients to be rescanned unnecessarily or result in undiagnosable images.
The software issues can cause the CT scanner to produce incorrect images, skip scans, or fail to save critical ECG data. This may lead to patients being rescanned unnecessarily or receiving undiagnosable images, especially if the scanner's orientation or dose settings are affected.
Users of Philips Incisive CT scanners in Brazil with product code 728146 and software versions 5.1.0.X or 5.1.1.X are most at risk. Healthcare providers using these scanners for medical imaging may face incorrect results or additional scans.
Check if your Philips Incisive CT scanner has product code 728146 and software versions 5.1.0.X or 5.1.1.X. This model was sold in Brazil for SKD (Service Kit Delivery) use.
Verify your scanner's software version by checking the device settings or documentation. If it is 5.1.0.X or 5.1.1.X, it is affected.
Contact Philips Medical Systems to obtain the software update that resolves these issues. The update will fix the problems with image quality and scan accuracy.
Philips Medical Systems identified multiple software issues in the Incisive CT scanners that could cause incorrect scans, rescans, or missing ECG data, potentially leading to undiagnosable images.
No, but you should check your software version and update it as soon as possible to avoid potential issues with scan accuracy.
Your scanner is affected if it has product code 728146 and software versions 5.1.0.X or 5.1.1.X, which were sold in Brazil for SKD use.
We’ve drafted a message you can send Philips Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0377-2026 — Philips Medical Systems Philips Medical Systems Hello, I own a Philips Medical Systems that is covered by recall Z-0377-2026 from Philips Medical Systems. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
