Brilliance Ict; Product Code (ref): 728306;
Recall Summary Philips is recalling Brilliance iCT CT scanner systems (model 728306) because fasteners that attach the rotor to the bearing in the gantry may not be properly tightened. If multiple fasteners are loose, rotor parts could potentially become unsecured or displaced and be ejected during scanner operation, though this has not been reported to occur. This recall affects facilities using this CT system model.
- Recalling firm
- Philips North America Llc
- Product
- Brilliance iCT; Product Code (REF): 728306;
- 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/23d8a203-13ee-4211-8141-3ba60745176a