FDAJanuary 7, 2026device

Spectral CT; Product Code (REF): 728333;

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.

What to do

FDA enforcement status: Ongoing

Brands named

philips north americaphilipsphilips north

UPCs

00884838101111

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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