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 human vascular system for diagnostic studies in magnetic resonance imaging (MRI) applications with MRI scanners that have a magnetic field strength between 0.7 and 3.0 Tesla. Only trained healthcare professionals are intended to operate this device.
FDA Recall Z-2244-2016 · Posted None
Recalling FirmBayer Healthcare
Recall StatusTerminated
Product CodeDXT
Date Initiated2016-06-09
Date Terminated2016-12-05
Product Quantity42 units
Reason for Recall
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide and the US state of NEW YORK
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.