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
- Affected units
- 128
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
Part of a larger recall action
This product is one of 3 recalled by PHILIPS MEDICAL SYSTEMS under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · PHILIPS MEDICAL SYSTEMS
See all →- HighPhilips Ingenuity CT Scanners Recalled Due to Bolus Tracking Trigger Issue
FDA (Devices) · 2026-08-05
- HighPhilips IQon Spectral CT Recalled Due to Automatic Scan Trigger Failure
FDA (Devices) · 2026-08-05
- HighPhilips Spectral CT on Rails recalled over three software issues
FDA (Devices) · 2026-04-22
- HighCT 5300 scanners recalled over six software faults affecting movement and dose
FDA (Devices) · 2025-11-05
- HighBrazil market CT scanner recalled over six software faults affecting movement
FDA (Devices) · 2025-11-05
Same hazard · device malfunction
See all →- HighHeartSine SAM Public Access Defibrillators Recalled for Damaged Membrane Tail
FDA (Devices) · 2026-09-16
- HighPhilips Incisive CT Recalled for Potential Failure to Trigger Clinical Scan
FDA (Devices) · 2026-09-02
- HighBD Needle Kit for Powered Driver Recall Due to Removal Difficulty
FDA (Devices) · 2026-08-26
- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- HighNeuroguard IEP Carotid Stent and Balloon System Recalled for Filter Failure Risk
FDA (Devices) · 2026-08-12