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
FDA Recall Z-2768-2016 · Posted None
Recalling FirmBayer Healthcare
Recall StatusTerminated
Product CodeDXT
Date Initiated2016-08-02
Date Terminated2016-12-09
Product Quantity165 systems
Reason for Recall
CertegraWorkstation when used in conjunction with the Medrad Stellant CT Injection System may exhibit thermal events, such as: smoke and sparks of fire.
Firm Action
Bayer Healthcare mailed an Urgent Field Safety Notification letter on August 03, 2016 to customers who were affected by the recall informing them of the issue and what actions to take if they were impacted. Customers were advised to use the enclosed Interim Instructions for Use for further information. For questions customers should call 1-877-229-3767.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide Distribution - US (nationwide) and Internationally to United Arab Emirates, Australia, Canada, Germany, Spain, and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.