Philips North America Recalls Spectral CT 7500 on Rails Over Potential Rotor Part Displacement

What Happened

Philips North America Llc has initiated a voluntary recall of the Spectral CT 7500 on Rails medical imaging system. The recall was prompted by the discovery that one or more 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 loose, the rotor or its components could become unsecured or displaced during use.

Which Products Are Affected

The recall involves three specific units of the following product:

• Product Name: Spectral CT 7500 on Rails
• Product Code (REF): 728334
• UDI-DI: 00884838103627
• Serial Numbers: 1005, 1007, 1008

The affected units were distributed within the United States to Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New York, Ohio, Oregon, Pennsylvania, Texas, Vermont, Washington, and West Virginia. International distribution also occurred across several dozen countries.

What You Should Do

Philips North America Llc began notifying affected customers via letter on January 7, 2026. Facilities possessing the units with serial numbers 1005, 1007, or 1008 should follow the specific guidance provided in the firm’s notification letter. For further information regarding the status of this recall (Recall Number: Z-1318-2026), healthcare providers should contact Philips North America Llc at their Cambridge, MA headquarters.

Why This Matters

While there have been no reported or observed events of parts being expelled during gantry rotation to date, unsecured rotor parts could potentially be expelled if the fasteners fail. This poses a safety risk to patients and clinical staff during the operation of the CT system.

Source

Information provided by the FDA.