CLASS II ONGOING Device recall · Reported 5 Nov 2025 · FDA Enforcement Report
Model: CT 5300; Product Code (REF): 728285; Software Versions recalled
Philips Medical Systems is recalling Model: CT 5300; Product Code (REF): 728285; Software Versions, distributed nationwide in the US. The recall was initiated on 25 Sep 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0376-2026
- FDA event ID
- 97699
- Recalling firm
- Philips Medical Systems, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Sep 2025
- FDA classified
- 27 Oct 2025
- Reported
- 5 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Medical Software
Timeline
| 25 Sep 2025 | Recall initiated by company | |
| 27 Oct 2025 | Classified by FDA | +32 days |
| 5 Nov 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;
Where it was distributed
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;
Nationwide AlabamaArkansasCaliforniaConnecticutFloridaGeorgiaIllinoisIndianaKentuckyMarylandMichiganOhioPennsylvaniaPuerto RicoTennesseeTexasUtahVirginia
Questions about this recall
Is Model: CT 5300; Product Code (REF): 728285; Software Versions recalled?
Yes. Philips Medical Systems recalled Model: CT 5300; Product Code (REF): 728285; Software Versions on 25 Sep 2025. The recall is Class II and its status is Ongoing. Recall number Z-0376-2026.
Why was it recalled?
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.
Which lots are affected?
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;
Where was it sold?
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;
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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