Philips North America Recalls Spectral CT Systems Due to Potential Rotor Component Displacement

What Happened

Philips North America Llc has initiated a voluntary recall of certain Spectral CT systems. The issue involves 32 fasteners used to attach the rotor to the bearing within the gantry. According to the firm, one or more of these fasteners may not have been torqued to the required specification. If multiple fasteners are not properly secured, the rotor or its components could become unsecured or displaced during operation.

Which Products Are Affected

The recall affects 283 units of the following medical device:

• Product Name: Spectral CT
• Product Code (REF): 728333
• UDI-DI: 00884838101111
• Serial Numbers: A total of 283 specific serial numbers are affected, including but not limited to 10055, 10075, 10086, 10106, 12009, 396013, and 398004 (see official FDA records for the complete list).

Geographic Scope: The products were distributed worldwide. In the United States, distribution occurred in 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. International distribution includes over 50 countries across Europe, Asia, South America, and the Middle East.

What You Should Do

Philips North America Llc began notifying customers via letter on January 7, 2026. Facilities and healthcare providers using these Spectral CT systems should review the notification letter for specific instructions regarding inspection or service. For further information, customers can contact Philips North America Llc at their Cambridge, MA headquarters located at 222 Jacobs St, 02141-2289.

Why This Matters

While there have been no reported or observed events of parts being expelled during gantry rotation, unsecured rotor parts could potentially be expelled if multiple fasteners fail. This poses a safety risk to anyone in the vicinity of the device during operation.

Source

Information provided by the FDA under Recall Number Z-1317-2026.