FDASeptember 20, 2013device
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 recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
medrad inc dba bayer r imedradmedrad inc
Recall history
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