Philips Brilliance iCT SP CT Scanner Recall Due to Bolt Issue
Philips is recalling two Brilliance iCT SP CT scanners because a cooling unit bolt was not tightened to specification.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The source text describes a mechanical defect (bolt not tightened to specification) without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity rating.
Plain-English summary
Philips North America, LLC is recalling two units of the Philips Brilliance iCT SP Computed Tomography X-Ray System, Model # 728311. The recall was initiated because the bolt affixing the cooling unit to the rotor was not tightened to specification.
The affected units were distributed worldwide, including one unit distributed to Iowa. The specific serial numbers identified in the recall are 200044 and 200026.
Healthcare facilities should contact Philips North America, LLC for instructions on how to resolve the issue with the affected equipment.
The recalled product
- Product
- Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311
- 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 (1)
- Serial # 200044 Additional unit as off 5/22/20: 200026
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 · mechanical defect
See all →- HighMobile Digital Radiographic System Arm Drop Risk During Patient Exams
FDA (Devices) · 2026-07-22
- ModerateSurgical driver systems recalled over out of the box driver wobble
FDA (Devices) · 2025-09-03
- HighBeckman Coulter DxI 9000 Analyzer wash wheel mixer defect may prevent operation
FDA (Devices) · 2025-03-19
- SevereBaxter Spectrum IQ Infusion System may have missing motor mounting screws
FDA (Devices) · 2025-03-12
- HighVNS Therapy Generator May Stop Delivering Stimulation Due to Mechanical Defect
FDA (Devices) · 2025-02-12