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FDA-Device2026-02-18Class IIPROCESSING DEFECT

Philips Spectral CT recalled for potentially loose rotor fasteners

Philips
OTHERNationwide distribution

Contact Philips about your Spectral CT system

Philips has recalled certain Spectral CT imaging systems because fasteners that hold the rotor in place inside the gantry may not be properly tightened. If multiple fasteners are loose, rotor parts could potentially become displaced or expelled during operation. No injuries or equipment failures have been reported so far.

  • Check if your Spectral CT system's serial number is on the recall list
  • Contact Philips or your service representative for inspection and correction
  • Do not operate the system until fasteners have been verified and corrected if needed
Hazard

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.

Sold states
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.
Affected count
283 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Spectral CT; Product Code (REF): 728333;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1317-2026

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