Philips Brilliance IQon Spectral CT Recall for Cooling Unit Bolt Issue
Philips is recalling two Brilliance IQon Spectral CT systems because a bolt on the cooling unit was not tightened to specification.
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: The recall is classified as FDA Class II, and the hazard involves a structural component (bolt) on a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Philips North America, LLC is recalling two units of the Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System (Model # 728332). The recall involves serial numbers 860067 and 860023. The agency classifies this as a Class II recall.
The recall is being issued because the bolt affixing the cooling unit to the rotor was not tightened to specification on the affected systems. The source text does not report any specific injuries, illnesses, or malfunctions resulting from this defect.
The affected units were distributed worldwide, including one unit distributed to Iowa. The source text does not provide specific instructions for consumers or healthcare facilities on how to proceed with the recall.
The recalled product
- Product
- Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model # 728332; UDI # (01)00884838059542(21)860067
- Manufacturer
- Philips North America, LLC
- Hazard
- Affected units
- 2
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 (2)
- Serial #s 860067
- 860023
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 recalled by Philips North America, LLC 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 North America, LLC
See all →- HighPhilips Recalls Cardiac Workstation 7000 Due to Inaccurate Heart Rate Data
FDA (Devices) · 2026-08-26
- HighPhilips Recalls Cardiac Workstation 5000 Units for Inaccurate Heart Rate Data
FDA (Devices) · 2026-08-26
- HighPhilips Avalon Fetal Monitor FM 30 Speaker Connector Assembly
FDA (Devices) · 2026-07-01
- ModeratePhilips Avalon Fetal Monitor FM20 Speaker Connector Assembly Recall
FDA (Devices) · 2026-07-01
- ModeratePhilips Telemetry Monitor 5500 Device Reset Risk Recall
FDA (Devices) · 2026-07-01
Same hazard · structural defect
See all →- HighCanon Medical Alphenix X-ray Systems Recalled for Loose Ceiling Screws
FDA (Devices) · 2026-09-02
- HighLight Boy Recalls GBX12SK Light Towers Due to Frame Bending Risk
NHTSA · 2026-09-01
- SevereKmaier Infant Walkers Recalled for Serious Fall Hazard
CPSC · 2026-08-27
- Highrestor3d Recalls Veritas Standard Glenoid Baseplates Due to Machining Defect
FDA (Devices) · 2026-08-26
- SevereFord Recalls 2026 Maverick, F-150, and Bronco Sport for Joint Issues
NHTSA · 2026-08-25