Recall Z-2768-2016 ยท DXT Injector And Syringe, Angiographic
Bayer Healthcare
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
| Date | Aug 2, 2016 |
| Status | Terminated |
| Reason | CertegraWorkstation when used in conjunction with the Medrad Stellant CT Injection System may exhibit thermal events, such as: smoke and sparks of fire. |
| Root cause | Under Investigation by 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. |
| Quantity | 165 systems |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to United Arab Emirates, Australia, Canada, Germany, Spain, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082905 | MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC Medrad, Inc., Jan 12, 2009 |