Philips CT Scanners Recalled Due to Bolus Tracking Trigger Issue
Philips is recalling certain CT scanners because the clinical scan may not start automatically after Bolus Tracking, which could require a patient rescan and expose them to additional radiation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported injuries; the hazard is a potential need for patient rescan and additional radiation, so it falls under risk-of-harm without reported injury (High).
Plain-English summary
Philips Medical Systems is recalling 128 CT scanner units, including Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP, Brilliance CT 64 Channel, CT6000, and Brilliance 64 Upgrades. The devices were distributed nationwide in the US, including Puerto Rico.
The recall was issued because the clinical CT scan may not automatically trigger after a Bolus Tracking scan and may need to be started manually. Additional Bolus Tracking shots may also occur. As a result, the clinical acquisition may be inadequate for diagnosis, which could lead to a patient being rescanned and receiving additional radiation.
The recall notice does not provide specific consumer instructions. Affected facilities should review the recall notice and contact Philips Medical Systems for more information.
The recalled product
- Product
- Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Hazard
- device-malfunction
- radiation-exposure
- diagnostic-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- FCO72800812
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighMedical Convenience Kits Recalled Over Endotoxin Variability in Neurological Sponges
FDA (Devices) · 2026-08-05
- HighStryker Hoffmann II Carbon Connecting Rods Recalled Over Potential Cracking After Sterilization
FDA (Devices) · 2026-08-05
- HighPeripherally Inserted Central Catheters Recalled Due to Hub Leaking and Cracking Risk
FDA (Devices) · 2026-08-05
- HighBlood Analyzer Bar Code Reader May Assign Patient Results to Incorrect Patient ID
FDA (Devices) · 2026-08-05
- ModerateMedical Convenience Kits Recalled Over Lidocaine Supplier Quality Issue
FDA (Devices) · 2026-08-05