Company: Philips North America
Date of Enforcement Report: 11/15/2023
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be restarted.
Philips North America
VOLUME OF PRODUCT IN COMMERCE:
US Nationwide distribution in the state of MN.