# FDA recall Z-3043-2026

> **Philips North America Llc** · Class II · device recall initiated 2026-08-07.

## 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 for recall

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.

## Distribution

US and US Territories.

## Key facts

- **Recall number:** Z-3043-2026
- **Recalling firm:** Philips North America Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-08-07
- **Report date:** 2026-09-09

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Cambridge, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3043-2026

## Citation

> MORVS. FDA recall Z-3043-2026. Retrieved 2026-10-18 from https://api.morvs.ai/recall/Z-3043-2026. Source: US FDA. Licensed CC0.

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