Philips Medical Systems: System, X-ray, Tomography, Computed

Philips Spectral CT on Rails Recall Summary Philips is recalling the Spectral CT on Rails (Model 728334) due to three software problems: the scanner gantry may not move to the correct position after a scan is started, required on-screen prompts may not appear, and certain menu options may be unavailable when adjusting brain scan settings. This recall affects CT scanners distributed nationwide in the United States, as well as in France and the Netherlands.

Recalling firm
PHILIPS MEDICAL SYSTEMS
Product
Philips Spectral CT on Rails. Model Number: 728334.
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.
Classification
Class II
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-03-07
Status
Open, Classified
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
Worldwide - US Nationwide distribution in the states of Minnesota and the countries of France and Netherlands.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/dbb7c463-9233-42d7-8ec8-f51bed437e69