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Medrad Inc dba Bayer R&I recalls MEDRAD¿ Stellant CT Injector System with Certegra Workstation; intended for the specific purpose of injecting intrav
Recalled June 3, 2015 · FDA recall Z-1686-2015 · Medrad Inc
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. · FDA Class II
Units
133
Sold at
Nationwide Distribution
Description
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.
Product
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.
Manufacturer(s)
Medrad Inc dba Bayer R&I
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →