FDA-Device2026-02-18Class IIPROCESSING DEFECT

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

OTHERNationwide distributionMedical devices

What this means

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

The agency's original wording

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.

Intended for

Adults

Illnesses reported

None reported

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

More Philips recalls

FDA-Device2026-09-09
Philips Brilliance iCT CT scanner recalled for unintended radiation issue
FDA-Device2026-09-09
Philips IQon Spectral CT recalled for unintended radiation issue affecting equipment performance
FDA-Device2026-09-09
Philips Ingenuity CT and related systems recalled for unintended radiation issue
FDA-Device2026-09-09
Philips Brilliance CT 64 systems recalled for unintended radiation issue
FDA-Device2026-07-01
Philips Telemetry Monitor 5500 recalled for potential device reset and loss of central monitoring connection

Want us to check the next one for you?

We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.