Iqon Spectral Ct; Product Code (ref): 728332;

Recall Summary Philips is recalling IQon Spectral CT systems (Product Code 728332) because fasteners that secure the rotor to the bearing in the gantry may not be tightened to the correct specification. If multiple fasteners are loose, the rotor or its parts could become unsecured or potentially dislodged during operation. No incidents have been reported to date.

Recalling firm

Philips North America Llc

Product

IQon Spectral CT; Product Code (REF): 728332;

Reason

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.

Classification

Class II

Category

consumer product recall

Country

United States

Agency

FDA-DEVICES

Recall date

2026-01-07

Status

Open, Classified

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/9b9093f9-209b-46bf-b899-246dc51c3df2