Quick Facts at a Glance
- Recall Date
- October 29, 2025
- Hazard Level
- HIGH
- Brand
- Philips North America
- 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 North America
- Product type
- CT Scanner
- Model numbers
- 1) Model Number: 728285, UDI-DI: 00884838113237, Serial Numbers: 35071, 800007, 800002, 800001, 800004, 800003
- 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
December 17, 2025
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
The Philips Incisive CT scanner is a medical imaging device used for diagnostic purposes in healthcare settings. These devices are crucial for obtaining detailed images of the body, aiding in accurate diagnosis and treatment planning.
Why This Is Dangerous
The risk arises from improperly tightened screws on the tube heat exchanger, which can lead to detachment during operation. This poses a danger as it may damage other essential components of the CT system.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects a limited number of devices, but immediate action is necessary to prevent potential damage to the CT system and ensure patient safety.
Practical Guidance
How to identify if yours is affected
- Check the model number and serial numbers of your CT scanner to verify if it is part of the recall.
- Look for the software version of your device; affected versions include 4.5, 5.0, and 5.1.
- Contact your healthcare provider or Philips North America for confirmation.
Where to find product info
Model numbers and serial numbers are typically found on the back or bottom of the device. Refer to the user manual for specific locations.
What timeline to expect
Expect a response regarding refund or replacement within 4-6 weeks after contacting Philips North America.
If the manufacturer is unresponsive
- Document all communication attempts with Philips North America.
- Contact the FDA or your local health authority for further assistance.
How to prevent similar issues
- Always check for recalls before purchasing medical devices.
- Stay informed about the latest safety standards and recalls in medical technology.
Documentation advice
Keep a record of all correspondence with Philips, including emails, letters, and any documentation related to the recall.
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Product Details
The recall affects the Incisive CT systems with software versions 4.5, 5.0, and 5.1. Model number 728285 and serial numbers include 35071, 800001, 800002, 800003, 800004, and 800007. The devices were distributed worldwide, including the US and various countries.
Key Facts
- Recall date: October 29, 2025
- Report date: December 10, 2025
- Quantity recalled: 6 units
- Hazard level: High
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