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Bayer Healthcare recalls Certegra Workstation used in conjunction with Medrad Stellant CT Injection System Catalog Number # CWKS DISPLAY Seria
Recalled September 14, 2016 · FDA recall Z-2768-2016 · Bayer Healthcare
Hazard
CertegraWorkstation when used in conjunction with the Medrad Stellant CT Injection System may exhibit thermal events, such as: smoke and sparks of fire. · FDA Class II
Units
165 systems
Sold at
Worldwide Distribution - US (nationwide) and Internationally to United Arab Emirates, Australia, Canada, Germany, Spain, and United Kingdom.
Description
CertegraWorkstation when used in conjunction with the Medrad Stellant CT Injection System may exhibit thermal events, such as: smoke and sparks of fire.
Product
Certegra Workstation used in conjunction with Medrad Stellant CT Injection System Catalog Number # CWKS DISPLAY Serial Numbers The Medrad Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications
Manufacturer(s)
Bayer Healthcare
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →