Quick Facts at a Glance
- Recall Date
- October 29, 2025
- Hazard Level
- HIGH
- Brand
- Philips
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Philips
- Product type
- CT Scanner System
- Model numbers
- 728143, UDI-DI 00884838085015
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 29, 2025
Reported by FDA DEVICE
December 10, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Philips North America Llc or your healthcare provider for instructions. Notification method: Letter
About This Product
Incisive CT is a computed tomography system used in hospitals for diagnostic imaging. It integrates rotating scanners and tube heat exchangers to acquire detailed body scans.
Why This Is Dangerous
If the screws on the tube heat exchanger are not tightened after replacement, a component may detach and contact other components during rotation. This could cause damage to the scanner assembly.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Hospitals may need to halt imaging work on affected units and schedule service to repair or replace components. Downtime could affect diagnostic workflows and patient care.
Practical Guidance
How to identify if yours is affected
- Verify software version installed on the unit (4.5, 5.0, or 5.1).
- Confirm model number on the device label is 728143.
Where to find product info
Serial numbers and UDI-DI appear on the device data plate and packaging. The recall letter will specify included units.
What timeline to expect
Timeline for refunds or replacements not specified in the recall notice.
If the manufacturer is unresponsive
- Document all communications with Philips; file a complaint with the FDA if the company is unresponsive; seek guidance from hospital risk management.
- Use FDA recall portals to report lack of response.
How to prevent similar issues
- Do not attempt to tighten screws yourself. Rely on trained service technicians.
- Maintain complete service records and recall communications for each unit.
- Verify other CT system components are inspected during service.
Documentation advice
Keep the recall notice, service paperwork, serial numbers, and correspondence. Take photos of the device labeling and any service actions.
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Product Details
Model Number: 728143. UDI-DI: 00884838085015. Serial Numbers: 500092, 500202, 500309, 500376, 500574, 500265, 500264, 510051, 500034, 500544, 500543, 500548, 500046, 500168, 500064, 500110, 500111, 500102. Sold worldwide to healthcare providers. Distribution: Worldwide distribution including US nationwide and many countries listed in the recall notice. Recall Date: 2025-10-29. Report Date: 2025-12-10. Quantity: 2341 units. Country of origin: Unknown. Remedial action: Stop using the device and follow recall instructions from Philips North America LLC.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 2,341 units recalled worldwide
- Model 728143 with UDI-DI 00884838085015
- Recall status: ACTIVE
- Remedy is to stop using and follow manufacturer instructions
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Safety Guide
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