Philips North America Recalls Spectral CT 7500 on Rails Over Potential Rotor Part Displacement
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Philips North America Llc is recalling three Spectral CT 7500 on Rails units because improperly torqued fasteners could cause rotor parts to become unsecured or expelled during operation.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on February 25, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
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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.
Original source: FDA Official Notice ↗
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