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FDA-Device2026-02-18Class IIPROCESSING DEFECT

Philips Spectral CT 7500 on Rails recalled for potentially loose rotor fasteners

Philips
OTHERNationwide distribution

Check your Philips Spectral CT 7500 fasteners

Philips has recalled three Spectral CT 7500 CT scanner systems because fasteners that secure the rotor inside the gantry may not have been tightened to the correct specification. If multiple fasteners are loose, rotor parts could become unsecured or displaced during operation. No parts have been expelled or injuries reported so far.

  • If you operate a Philips Spectral CT 7500 with serial number 1005, 1007, or 1008, contact Philips immediately
  • Do not operate the affected scanner until fasteners are inspected and retorqued to specification by a qualified technician
  • Verify that all 32 rotor fasteners meet torque specifications before resuming patient scans
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
3 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Spectral CT 7500 on Rails; Product Code (REF): 728334;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1318-2026

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