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U.S. Department of Health and Human Services

Class 2 Device Recall MEDRAD MRXerion MR Injection System

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  Class 2 Device Recall MEDRAD MRXerion MR Injection System see related information
Date Initiated by Firm June 09, 2016
Create Date July 19, 2016
Recall Status1 Terminated 3 on December 05, 2016
Recall Number Z-2244-2016
Recall Event ID 74513
510(K)Number K143538  
Product Classification Injector and syringe, angiographic - Product Code DXT
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.
Code Information Catalog numbers: MRXP 200 Serial numbers: 100009, 100011, 100019, 100020, 100022, 100026, 100027, 100028, 100036, 100047, 100065, 100066, 100069, 100074, 100075, 100085, 100090, 100091, 100096, 100097, 100098, 100099, 100100, 100101, 100103, 100104, 100106, 100107, 100108, 100109, 100110, 100111, 100112, 100113, 100114, 100118, 100119, 100129, 100152, 100155, 100161, 100166
Recalling Firm/
Manufacturer		 Bayer Healthcare
1 Bayer Dr
Indianola PA 15051-9702
For Additional Information Contact
412-767-2400
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 42 units
Distribution Worldwide and the US state of NEW YORK
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DXT and Original Applicant = BAYER MEDICAL CARE INC.
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