—#218016

Product

Spectral CT 7500 on Rails; Product Code (REF): 728334;

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K212875
Affected lot / code info: Product Code (REF): 728334; UDI-DI: 00884838103627; Serial Numbers: 1005, 1007, 1008;

Why it was recalled

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.

Root cause (FDA determination)

Process change control

Action the firm took

On or about January 7, 2026 URGENT Medical Device Correction letters were sent to customers. Actions to be taken: 1. As a precaution, monitor the gantry for any unusual sounds or vibrations during operation. If unusual sounds are heard or vibrations are observed, immediately call your service contact. In the absence of unusual sounds or vibrations, you may continue to use your system(s) according to the intended use. 2. Circulate this Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue. Please retain this letter with your system(s) until Philips has inspected your system and has provided any correction, if needed. Ensure the letter is in a place likely to be seen and read. Actions planned by Philips: Philips will contact you to schedule a time for a Philips Field Service Engineer (FSE) to visit your site and to inspect the fasteners on your system (reference FCO72800845). If the inspection indicates that your system is affected, Philips will perform the correction to resolve the issue (reference FCO72800846)

Recalling firm

Firm: Philips North America Llc
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2289

Distribution

Distribution pattern: Worldwide - US Nationwide distribution in the states of AL, AR, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MD, MN, NC, NY, OH, OR, PA, TX, VT, WA, WV 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.

Timeline

Recall initiated: 2026-01-07
Posted by FDA: 2026-02-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #218016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.