Philips North America Llc: Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Philips North America Llc
- Product
- Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x
- Reason / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US and US Territories.
- Recall initiated
- 2026-08-07
- Code info
- Brilliance CT 64 Channel UDI (01)00884838083325. Brilliance CT 64 Upgrades UDI N/A.
- Product quantity
- N/A
- Voluntary mandated
- FDA Mandated
- City
- Cambridge
- State
- MA
- Country
- United States
- Event id
- 99784
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