Drug recall
Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64…
FDA recall event 99352 · Class II · PHILIPS MEDICAL SYSTEMS
Key facts
| Event ID | 99352 |
|---|---|
| Recall numbers | Z-2650-2026, Z-2651-2026, Z-2652-2026 |
| Recalling firm | PHILIPS MEDICAL SYSTEMS |
| Product type | Devices |
| Products | Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades, Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 128 Elite Brazil, IQon Spectral CT IQon Spectral CT Upgrades |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA Requested |
| Reason for recall | The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical… |
| Initiation date | Jun 11, 2026 |
| Report date | Aug 5, 2026 |
| City | Cambridge |
| State | MA |
| Country | United States |
| FEI number | 3017726341 |
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: