FDA-Device2015-06-03Class II
MEDRAD¿ Stellant CT Injector System with Certegra Workstation; intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications.
Medrad Inc dba Bayer R&I
Hazard
The root cause investigation showed that the under-volume hazard can occur when the unit has been configured to prime with contrast, but instead primes with saline due to the configuration data not being sent to the injector head. This may create a non-optimal priming condition that could lead to under-infusion.
Sold states
Nationwide Distribution
Affected count
133
Manufactured in
1 Medrad Dr, Indianola, PA, United States
Products
MEDRAD¿ Stellant CT Injector System with Certegra Workstation; intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1686-2015Don't want to check this manually?
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