Quick Facts at a Glance
- Recall Date
- January 7, 2026
- 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
- Product Code (REF): 728333, UDI-DI: 00884838101111, Serial Numbers: 10055, 10075, 10086, 10096, 10106, 10116 +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 7, 2026
Reported by FDA DEVICE
February 18, 2026
RecallRadar source check
February 25, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
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 Spectral CT is a medical imaging device used for diagnostic purposes in healthcare settings. Healthcare providers rely on this equipment for accurate imaging and assessments of patients.
Why This Is Dangerous
Improperly torqued fasteners may cause the rotor and its parts to become unsecured. This malfunction could lead to serious safety risks if the rotor parts are expelled during operation.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must cease usage of the device, which could disrupt medical procedures and patient care.
Practical Guidance
How to identify if yours is affected
- Check the product code and serial numbers against the recall list.
- Verify if your device was distributed in the listed states or countries.
- Contact Philips North America directly for confirmation.
Where to find product info
Serial numbers can typically be found on the device's identification plate or packaging.
What timeline to expect
Expect a timeline of 4-6 weeks for processing refunds or replacements once initiated.
If the manufacturer is unresponsive
- Document all correspondence with Philips North America.
- Consider escalating the issue through relevant health authorities or consumer protection agencies.
How to prevent similar issues
- Ensure new medical devices meet current safety standards.
- Ask for detailed safety records before purchasing medical equipment.
- Stay informed about recalls in the medical device industry.
Documentation advice
Keep records of all communications, including emails and phone calls, along with any receipts or documents related to the purchase.
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Product Details
The recalled product is the Spectral CT with Product Code (REF): 728333. Model numbers include UDI-DI: 00884838101111 and serial numbers ranging from 10055 to 10237. It was distributed worldwide, including across the United States and various countries.
Key Facts
- Recalled product: Spectral CT
- Quantity recalled: 283 units
- Risk of unsecured rotor parts
- No reported incidents of expulsion
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Safety Guide
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