BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-2244-2016 · Initiated June 9, 2016

    Recall

    Recall Number
    Z-2244-2016
    Event Number
    74513
    Firm
    Bayer Healthcare
    FEI Number
    2520313
    Product Code
    DXT
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 9, 2016
    Terminated
    December 5, 2016
    Address
    1 Bayer Dr, Indianola, PA, 15051-9702

    Description

    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.

    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.

    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.

    Distribution

    Worldwide and the US state of NEW YORK

    Quantity

    42 units