Warning
PHILIPS MEDICAL SYSTEMS Recalls Philips Spectral CT on Rails
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-1825-2026Medical Device
PHILIPS MEDICAL SYSTEMS Recalls Philips Spectral CT on Rails
PHILIPS MEDICAL SYSTEMS · Class II — Moderate Risk
Product Description
Philips Spectral CT on Rails. Model Number: 728334.
Reason for Recall
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.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Worldwide - US Nationwide distribution in the states of Minnesota and the countries of France and Netherlands.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database