FDA-Device2026-02-18Class IIPROCESSING DEFECT

Philips Brilliance iCT CT scanner recalled for potentially loose rotor fasteners

OTHERNationwide distributionMedical devices

What this means

Philips has recalled certain Brilliance iCT CT scanners because fasteners that secure the rotor inside the gantry may not be tightened to the correct specification. If multiple fasteners are loose, rotor parts could potentially become displaced or expelled during scanning. No injuries or incidents have been reported.

If your facility operates one of the affected serial numbers (87064–87221), contact Philips immediately
Do not operate the scanner until Philips confirms your unit's fasteners are properly torqued
Provide your equipment serial number when contacting Philips for inspection and correction

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

47 units

Manufactured in

222 Jacobs St, N/A, Cambridge, MA, United States

Products

Brilliance iCT; Product Code (REF): 728306;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1315-2026

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