# FDA recall Z-0319-2024

> **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

This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the desired needle position. This issue could result in the gantry moving to a location the operator does not expect. If this occurs, it presents a risk that the scan could occur at an incorrect location, or that the unintended motion of the gantry could cause a collision with the user or needle.    The other part of the recall involves a software crash when the CCT foot pedal is activated (as described in RES ID93363).

## Distribution

US Nationwide distribution in the state of MN.

## Key facts

- **Recall number:** Z-0319-2024
- **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-0319-2024

## Citation

> AI Analytics. FDA recall Z-0319-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0319-2024. Source: US FDA. Licensed CC0.

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