Philips North America Recalls IQon Spectral CT Systems Due to Loose Fastener Risk

What Happened

Philips North America Llc has initiated a voluntary recall of certain IQon Spectral CT systems. The recall was prompted by the discovery that some of the 32 fasteners used to attach the rotor to the bearing within the gantry may not have been torqued to the correct specification. If multiple fasteners are not properly secured, the rotor or its components could become displaced. While there have been no reports of parts being expelled during gantry rotation to date, the defect poses a potential risk that unsecured rotor parts could be expelled during operation.

Which Products Are Affected

The recall affects 52 units of the following medical device:

• Product Name: IQon Spectral CT
• Product Code (REF): 728332
• UDI-DI: 00884838059542
• Affected Serial Numbers: 60128, 60141, 60151, 60161, 60171, 60181, 60129, 60142, 60152, 60162, 60172, 60182, 60130, 60143, 60153, 60163, 60173, 60132, 60144, 60154, 60164, 60174, 60133, 60145, 60155, 60165, 60175, 60134, 60146, 60156, 60166, 60176, 60136, 60147, 60157, 60167, 60177, 60137, 60148, 60158, 60168, 60178, 60138, 60149, 60159, 60169, 60179, 60139, 60150, 60160, 60170, 60180.

This recall impacts distribution in 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, WV) and over 50 countries worldwide.

What You Should Do

Philips North America Llc initiated the recall on January 7, 2026, by sending notification letters to affected customers. Healthcare facilities and providers using the IQon Spectral CT system should check their equipment’s serial numbers against the list of affected units. Owners of affected devices should follow the specific instructions provided in the firm’s notification letter regarding inspection and repair of the gantry fasteners.

Why This Matters

This recall is significant because it addresses a mechanical failure risk in a high-speed medical imaging device. Properly torqued fasteners are critical to ensuring the structural integrity of the gantry during rotation, preventing potential injury to patients or medical staff from expelled mechanical parts.

Source

This information is based on an official FDA recall notice (Recall Number: Z-1316-2026).