FDAFDA · Food and drugs·Recall number Z-2651-2026
IQon Spectral CT IQon Spectral CT Upgrades
Published August 5, 2026 · Recall initiated: June 11, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.
What to do
FDA Mandated · Letter
Recall details
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Distributor
- US Nationwide Distribution including Puerto Rico
- Lot
- FCO72800812; FCO72800814 728331 728332, DI (01)00884838059542
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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