FDA-Device2023-11-22Class II
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Hazard
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.
Sold states
US Nationwide distribution in the state of MN.
Affected count
1 unit
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0306-2024Don't want to check this manually?
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