Company: Philips North America
Date of Enforcement Report: 11/15/2023
Class II
PRODUCT
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Recall Number:
Z-0306-2024
REASON:
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.
RECALLING FIRM/MANUFACTURER:
Philips North America
VOLUME OF PRODUCT IN COMMERCE:
1 unit
DISTRIBUTION:
US Nationwide distribution in the state of MN.
