Spectral Ct; Product Code (ref): 728333;

Spectral CT Recall Summary Philips is recalling Spectral CT systems (model 728333) because fasteners that secure the rotor to the bearing in the gantry may not be properly tightened. If multiple fasteners are loose, rotor parts could become unsecured or potentially expelled during operation. No incidents have been reported so far.

Recalling firm

Philips North America Llc

Product

Spectral CT; Product Code (REF): 728333;

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/9317794d-7152-4a1a-8c2f-c515216e3f45