Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231 recall (Philips North America Llc)
Medical deviceClass IIOngoing
Summary: Philips North America Llc is recalling Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x. 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.
What is being recalled
Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US and US Territories.
How to tell if yours is affected
Brilliance CT 64 Channel UDI (01)00884838083325. Brilliance CT 64 Upgrades UDI N/A.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3043-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 7, 2026 |
| Reported | September 9, 2026 |
| Company | Philips North America Llc |
| Company location | Cambridge, MA, United States |
| Initiated by | FDA Mandated |
| Quantity | N/A |
More recalls from Philips North America Llc · all medical device recalls · recalls from August 2026