Recall Weekly← all recalls
FDA-Device2026-02-18Class IIPROCESSING DEFECT

Philips IQon Spectral CT scanner recalled for potentially loose rotor fasteners

Philips
OTHERNationwide distribution

Contact Philips about your IQon Spectral CT

Philips has identified that fasteners holding the rotor in place inside certain IQon Spectral CT scanners may not be properly tightened. While no equipment failures or injuries have been reported, loose fasteners could theoretically cause rotor parts to become unsecured during operation.

  • Check if your facility has one of the 52 affected serial numbers listed in this recall
  • Contact Philips if you own an affected unit to arrange inspection and repair
  • Do not use the equipment until Philips confirms the fasteners are properly secured
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
52 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
IQon Spectral CT; Product Code (REF): 728332;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1316-2026

More Philips North America Llc recalls

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief