Recall Z-2244-2016 ยท DXT Injector And Syringe, Angiographic
Bayer Healthcare
Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit Usage: The MEDRAD MRXperion MR Injection System is a syringe based fluid delivery system indicated for delivery of contrast media and saline during MR applications. It is intended to be used for the specific purpose of injecting intravenous MR contrast media and saline into the hum
| Date | Jun 9, 2016 |
| Status | Terminated |
| Reason | Bayer Healthcare is initiating this recall due to complaints that were received from customer sites describing a 4205 error message when the injector is used with a 3T scanner. |
| Root cause | Device Design |
| Action | Bayer sent an Urgent Medical Device Field Corrective Action letter dated June 8, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to take the following steps should a 4205 error message is encountered. For questions contact Bayer Customer Support Team at 1-800-633-7237. |
| Quantity | 42 units |
| Distribution | Worldwide and the US state of NEW YORK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143538 | MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit Bayer Medical Care, Inc., Aug 14, 2015 |