Spectral CT recallZ-1317-2026 · Philips North America Llc · initiated Jan 7, 2026

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.

FDA root cause category: Process change control

What the company is doing

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)

Recall details

Recall number

Z-1317-2026

Status

Open, Classified

Initiated by the company

Jan 7, 2026

Posted by the FDA

Feb 6, 2026

Recalling firm

Philips North America Llc

Quantity

283 units

Product code

JAK

FDA submissions

K244008

Distribution

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.

Product description

Spectral CT; Product Code (REF): 728333;

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Spectral CT

  Philips Medical Systems Nederland B.V. · System, x-ray, tomography, computed
  11 recalls3 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 98248).

• Z-1315-2026 · Open, Classified
  Brilliance iCT; Product Code (REF): 728306;
• Z-1316-2026 · Open, Classified
  IQon Spectral CT; Product Code (REF): 728332;
• Z-1318-2026 · Open, Classified
  Spectral CT 7500 on Rails; Product Code (REF): 728334;