Bayer Healthcare recalls Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit

Recalled July 27, 2016 · FDA recall Z-2244-2016 · Bayer Healthcare

Hazard

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. · FDA Class II

Units

42 units

Sold at

Worldwide and the US state of NEW YORK

Description

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.

Product

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.

Manufacturer(s)

Bayer Healthcare

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →