Philips Brilliance iCT Recall Over Unintended Radiation Issue
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Philips North America Llc is recalling Brilliance iCT CT systems due to an unintended radiation issue that could affect equipment performance.
Reading this FDA recall beyond the headline
This notice was issued by FDA on September 15, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.", distributed us and us territories.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
A quick skim tells you whether this affects you directly; a closer read tells you more. Check the scope, the source, and how recent the record is, then weigh it against related notices rather than treating any single one as a trend.
Before acting, the primary agency source is available to check alongside this summary. Its related labels are recall, product-safety, fda, Devices.
What Happened
Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
Which Products Are Affected
Philips Brilliance models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x. Product Codes: 728306, 728305, 728311. UDI for Brilliance iCT: (01)00884838059474. Distribution in US and US Territories. Recall number Z-3040-2026. Classification: Class II.
What You Should Do
Consumers should contact Philips North America Llc for further information regarding the recall.
Why This Matters
The recall involves CT imaging systems distributed across the United States and its territories.
Source
FDA recall Z-3040-2026, event ID 99784.
Original source: FDA Official Notice ↗
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Comparable nationwide notices (length or severity timing) 8
Beyond this FDA recall's own category, Areazine surfaces two nationwide peer sets: length-matched and severity/date-matched notices from elsewhere in the archive, distinct from the same-feed Related list above.
Similar body length
Nearest notices by article body length (796 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 15, 2026.
Common Questions
Questions readers often have about this FDA recall.