| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00828-1 |
| Product Name/Description |
Medrad MRXperion MR Injection System
Catalogue Number: MRXP 200
ARTG Number: 156857 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/06/2016 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Bayer, has identified that a 4205 error message may occur when MRXperion is installed in a Magnetic Resonance Imaging suite which houses a 3T MR scanner. The occurrence of a 4205 error message is the result of electromagnetic interference when the MRXperion is exposed to radio frequency (RF) energy during certain pulse sequences on 3T scanners. This error message indicates an internal communication error within the device and may require a re-boot of the injection system.
If the 4205 error message occurs during a contrast-enhanced MR procedure, users of affected systems may experience the need to repeat the injection and imaging procedure. Also, an alternative diagnostic imaging procedure may be required. There have been no patient or user injuries reported as a result of this situation. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Imaxeon is advising users if they encounter a 4205 error message to take the following steps:
- With the patient on the table, assess whether to re-boot the MRXperion and proceed with the current scan, proceed with a hand injection if procedure permits, or select an alternate field strength scanner or imaging study.
- If the error occurs when the injector is powered on but not in use, then consider re-booting the MRXperion.
Imaxeon will be implementing a hardware and software upgrade to permanently correct the issue. This action has been closed-out on 18/05/2017. |
| Contact Information |
1800 633 724 - Imaxeon Customer Support Team |