Recall Z-2244-2016— Bayer Healthcare

Name: FDA recall Z-2244-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-09

Class II · Terminated

Class II FDA medical device recall by Bayer Healthcare, initiated 2016-06-09, terminated 2016-12-05. It names one FDA 510(k) clearance: K143538. 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.. 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..

Recalling firm: Bayer Healthcare
Classification: Class II
Status: Terminated
Initiated: 2016-06-09
Terminated: 2016-12-05
Firm location: Indianola, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K143538 — MRXperion MR Injection System, MRXperion MR Injection System Syringe KitBayer Medical Care, Inc.·cleared 2015-08-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.