Philips North America Recalls Brilliance iCT Systems Over Potential Projectile Hazard

What Happened

Philips North America Llc has initiated a voluntary recall of the Brilliance iCT system due to a mechanical assembly defect. Within the CT system’s gantry, thirty-two (32) fasteners are used to attach the rotor to the bearing. Investigations revealed that one or more of these fasteners may not have been torqued to the required specification. If multiple fasteners fail to meet these specifications, the rotor or its components may become unsecured or displaced. This creates a risk where rotor parts could potentially be expelled during gantry rotation.

Which Products Are Affected

The recall affects 47 units of the following medical device:

• Product Name: Brilliance iCT
• Product Code (REF): 728306
• UDI-DI: 00884838059474
• Recall Number: Z-1315-2026
• Serial Numbers: 87064, 87120, 87121, 87122, 87125, 87126, 87127, 87128, 87129, 87130, 87135, 87143, 87148, 87152, 87153, 87157, 87160, 87162, 87167, 87173, 87174, 87176, 87181, 87197, 87198, 87199, 87200, 87202, 87203, 87204, 87205, 87206, 87207, 87208, 87209, 87210, 87211, 87212, 87213, 87214, 87215, 87216, 87217, 87218, 87219, 87220, 87221.

The affected units were distributed worldwide, including 24 U.S. states: AL, AR, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MD, MN, NC, NY, OH, OR, PA, TX, VT, WA, and WV.

What You Should Do

Philips North America Llc notified affected customers via an initial firm notification letter sent on January 7, 2026. Facilities using the Brilliance iCT system should check their serial numbers against the provided list. If your unit is affected, follow the specific guidance provided in the notification letter from Philips.

Why This Matters

While there have been no reported incidents of parts being expelled to date, the potential for unsecured rotor components to be ejected during high-speed rotation poses a significant safety hazard to both patients and medical staff.

Source

Information provided by the FDA.