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): 728332, UDI-DI: 00884838059542, Serial Numbers: 60128, 60141, 60151, 60161, 60171, 60181 +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 IQon Spectral CT is a medical imaging device used for detailed imaging in various healthcare settings. It is often employed in diagnostic procedures to assist healthcare professionals in evaluating patient conditions.
Why This Is Dangerous
If the fasteners that secure the rotor are improperly torqued, there is a risk that rotor parts may become unsecured, which could lead to parts being expelled during operation, posing a serious safety hazard.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects the operational safety of medical imaging procedures. Healthcare facilities must cease use of the affected units, which could lead to temporary disruption in diagnostic services.
Practical Guidance
How to identify if yours is affected
- Locate the product code on the device, which is REF: 728332.
- Check the serial number against the list provided in the recall notice.
- Ensure that the device is not in use and has been powered down.
Where to find product info
The product code and serial numbers can typically be found on the back or underside of the device, near the power supply.
What timeline to expect
Expect a refund processing timeline of approximately 4-6 weeks after following the recall instructions.
If the manufacturer is unresponsive
- Contact Philips North America again to follow up on your request.
- Document all communications with Philips for your records.
- Consider reporting your issue to the FDA if no response is received.
How to prevent similar issues
- Ensure that staff are trained to recognize and report any anomalies in device operation.
Documentation advice
Keep records of all communications with Philips, including emails, letters, and phone call notes.
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Product Details
The recalled product is the IQon Spectral CT, Product Code (REF): 728332. It was distributed worldwide, including across 15 states in the U.S. and several countries, with a total of 52 units affected.
Key Facts
- Recall date: January 7, 2026
- Report date: February 18, 2026
- Affected states: AL, AR, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MD, MN, NC, NY, OH, OR, PA, TX,
- Quantity recalled: 52 units
- Hazard level: High
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Safety Guide
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