# FDA recall Z-0306-2024

> **Philips North America** · Class II · device recall initiated 2023-10-09.

## Product

Spectral CT on Rails, Software Version 5.1.0, Model Number 728334

## Reason for recall

When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be restarted.

## Distribution

US Nationwide distribution in the state of MN.

## Key facts

- **Recall number:** Z-0306-2024
- **Recalling firm:** Philips North America
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-09
- **Report date:** 2023-11-22

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0306-2024

## Citation

> AI Analytics. FDA recall Z-0306-2024. Retrieved 2026-07-30 from https://api.ai-analytics.org/recall/Z-0306-2024. Source: US FDA. Licensed CC0.

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