FDA Recall: Various software issues identified

Company: Philips Medical Systems
Date of Enforcement Report: 4/16/2026
Class: II

PRODUCT:

Philips Spectral CT on Rails. Model Number: 728334

Recall Number:

Z-1825-2026

REASON:

Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of Previous Surview Exists Select Previous Surview? or should display but does not appear. 3. After performing Surview and planning the Brain Helical acquisition by setting Brain Area DoseRight Index to increase the dose, there is the potential that the Define Head Area option in the context menu is grayed out.

RECALLING FIRM/MANUFACTURER:

PHILIPS MEDICAL SYSTEMS

VOLUME:

3 systems

DISTRIBUTION:

Worldwide – US Nationwide distribution in the states of Minnesota and the countries of France and Netherlands.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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