Medical device recalls Moderate risk

PHILIPS MEDICAL SYSTEMS recalls Philips Spectral CT on Rails. Model Number: 728334.

Recall date
March 7, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1825-2026
FDA classification
Class II
Brand / firm
PHILIPS MEDICAL SYSTEMS
Sold / distributed
Worldwide - US Nationwide distribution in the states of Minnesota and the countries of France and Netherlands.

Why it was recalled

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? <Yes> or <No> 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Philips Spectral CT on Rails. Model Number: 728334.

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