Philips recalls CT 5300 scanners with specific software versions due to risks of incorrect scans, missing ECG data, and radiation errors. Affected units may need re-scanning or rescan due to software faults.
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 CT 5300 medical scanners with certain software versions because they can cause incorrect scans, missing ECG data, and radiation errors. This may lead to patients needing rescan or undiagnosable images.
The software issues can cause the scanner to produce noisy images, skip images, or deliver radiation in the wrong orientation. This may lead to incorrect diagnoses or the need for rescanning patients.
Healthcare providers using Philips CT 5300 scanners with software versions 5.1.0.X or 5.1.1.X are most at risk. Patients may need rescan if images are incorrect.
Check for the model number CT 5300, product code 728285, and software versions 5.1.0.X or 5.1.1.X. Serial numbers listed in the recall include many starting with 8000 or 3500.
Verify your scanner's software version by checking the device settings or documentation.
Reach out to Philips for guidance on whether your unit needs correction or rescan.
Philips identified software issues that can cause incorrect scans, missing ECG data, and radiation errors, potentially requiring rescan of patients.
No, but you should check your software version and contact Philips to see if your unit needs correction or rescan.
The scanner may produce incorrect images or radiation errors, leading to undiagnosable scans or the need for rescan.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-0376-2026 — Philips Philips Hello, I own a Philips that is covered by recall Z-0376-2026 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.
