--- title: "Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.... — FDA record Z-0376-2026 | Is It on Recall" description: "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 perfo" url: https://isitonrecall.com/recall/fda-device-z-0376-2026-model-ct-5300-product-code-ref-728285-software-versions-5-1-0-x-5-1-1-x/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X; — FDA record Z-0376-2026 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Sep 25, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X; - **Reason**: 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. - **Classification**: Class II - **Recalling firm**: PHILIPS MEDICAL SYSTEMS - **Quantity**: 165 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0376-2026 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0376-2026%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | Product Code (REF): 728285; UDI-DI: 00884838113237; Serial Numbers: 800031, 800073, 800070, 35064, 35056, 35043, 35029, 800084, 800083, 800076, 800063, 800058, 800048, 800040, 800039, 800038, 800034, 800033, 800028, 800026, 800021, 800018, 800015, 800011, 800010, 800078, 800071, 35078, 35068, 35048, 35036, 800023, 800008, 800004, 800001, 35073, 35069, 35067, 35058, 35051, 35044, 35034, 35031, 35027, 35019, 35015, 35009, 35001, 800065, 35062, 35042, 35040, 35022, 35016, 35059, 800081, 800062, 800003, 35081, 35065, 35061, 35057, 35053, 35052, 35045, 35041, 35035, 35008, 800005, 35006, 800041, 35080, 800056, 35070, 35033, 35021, 800079, 800077, 800069, 800055, 800054, 800053, 800052, 800007, 800002, 35079, 35071, 35063, 35055, 35046, 35017, 35011, 35007, 35002, 800075, 800045, 800044, 800043, 800029, 800027, 800025, 800024, 800016, 800013, 800009, 800051, 800042, 800061, 800046, 800030, 800019, 800014, 800006, 800074, 800066, 35054, 35018, 800060, 800059, 800072, 35032, 35023, 35003, 800080, 800047, 35039, 35038, 35004, 76001, 35077, 35066, 35060, 35030, 35025, 35013, 35012, 35010, 35037, 35082, 35072, 35005, 35026, 800057, 800067, 800037, 800036, 800032, 800020, 35076, 35075, 35074, 35050, 35049, 35047, 35028, 35024, 35020, 35014, 800050, 800049, 800082, 800064, 800022, 800017, 800012; | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution 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; States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [California](https://isitonrecall.com/state/california/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) ## Dates in the source - **Report date**: Nov 5, 2025 - **Recall initiation date**: Sep 25, 2025 - **Center classification date**: Oct 27, 2025 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0376-2026%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [PHILIPS MEDICAL SYSTEMS records](https://isitonrecall.com/brand/philips-medical-systems/)