FDA recall, , Moderate risk
Philips Brilliance iCT and Spectral CT Scanners
Spectral CT 7500 on Rails may have fasteners not torqued to specification, potentially causing rotor parts to become unsecured and expelled.
Summary by Recall Canary from the FDA notice
What happened
Philips North America Llc, of Cambridge, Massachusetts, recalled Brilliance iCT, Spectral CT, IQon Spectral CT, and Spectral CT 7500 on Rails systems because one or more of the thirty-two fasteners attaching the rotor to the bearing within the gantry may not be torqued to specification, which could cause the rotor or rotor parts to become unsecured or displaced.
The recall began January 7, 2026, and was added to the FDA's Enforcement Report on February 6, 2026. The systems were distributed nationwide in 24 states and internationally in the countries listed in the notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
4 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Brilliance iCT; Product Code (REF): 728306;
- UDI-DI
- 00884838059474
Spectral CT; Product Code (REF): 728333;
- UDI-DI
- 00884838101111
IQon Spectral CT; Product Code (REF): 728332;
- UDI-DI
- 00884838059542
Spectral CT 7500 on Rails; Product Code (REF): 728334;
- UDI-DI
- 00884838103627
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New York, Ohio, Oregon, Pennsylvania, Texas, Vermont, Washington, West Virginia and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Lithuania, Macao, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, R¿union, Russian Fed., Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkmenistan, United Kingdom, Uzbekistan, Vietnam.
- Company
- Philips North America LlcCambridge, Massachusetts
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98248
- Recall numbers
- Z-1315-2026 to Z-1318-2026
All recalls from Philips North America Llc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
