Recall Z-1686-2015 ยท DXT Injector And Syringe, Angiographic
Medrad Inc dba Bayer R&I
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.
| Date | May 28, 2015 (initiated Sep 20, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | Bayer Healthcare sent a Medical Device Field Corrective Action letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify any affected device. Bayer Service will schedule time to update their software free of charge. Customers with questions were instructed to contact the customer support team at 1-800-633-7237. For questions regarding this recall call 412-767-2400. |
| Quantity | 133 |
| Distribution | Nationwide Distribution |
| 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 |