🟡
Class II
May cause reversible problems
🩺Dispositivo médico#Z-2651-2026
IQon Spectral CT IQon Spectral CT Upgrades
What happened?
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 should I do now?
- 1Check the lot number on your product packaging.
- 2If you have it, stop using it.
- 3Return it to your pharmacy or store for a refund.
- 4If you already used it and feel unwell, see your doctor immediately.
- 5Report adverse effects to the FDA: 1-800-FDA-1088.
- Company
- PHILIPS MEDICAL SYSTEMS
- Status
- Ongoing
- Report date
- 2026-08-05
- Initiated
- 2026-06-11
- Distribution
- US Nationwide Distribution including Puerto Rico
- Quantity
- 42
This is NOT medical advice. Consult with your pharmacist or doctor before making decisions.