Drug recall
Brilliance iCT; Product Code (REF): 728306;
FDA recall event 98248 · Class II · Philips North America Llc
Key facts
| Event ID | 98248 |
|---|---|
| Recall numbers | Z-1315-2026, Z-1316-2026, Z-1317-2026, Z-1318-2026 |
| Recalling firm | Philips North America Llc |
| Product type | Devices |
| Products | Brilliance iCT; Product Code (REF): 728306;, IQon Spectral CT; Product Code (REF): 728332;, Spectral CT 7500 on Rails; Product Code (REF): 728334;, Spectral CT; Product Code (REF): 728333; |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | Jan 7, 2026 |
| Report date | Feb 18, 2026 |
| City | Cambridge |
| State | MA |
| Country | United States |
| FEI number | 3016618143 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: