| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01312-1 |
| Product Name/Description |
MEDRAD Veris MR Vital Signs Monitor
Monitor serial numbers : 31710, 31031, 32507, 32551, 32884, 32897, 36417, 38312
Monitors containing main board (P/N 3010641) lot numbers 21-39
ARTG number: 118213 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
11/12/2013 |
| Responsible Entity |
|
| Reason/Issue |
Bayer Healthcare has identified that the main board, P/N 301641, installed in some MEDRAD Veris MR Monitors units may be faulty and could lead to unexpected shutdown of the system while in use. This would result in the loss of vital signs information from the monitor. Failure of the monitor may not only result in an inability of the user to view vital signs information but this failure may also go unrecognised. This may present an increased risk to patients who required that their vital signs be monitored while undergoing an MRI exam such as those who are sedated, anesthetised or who are on critical medications. Thus, it is required to continually monitor the system to ensure proper functioning. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
For those with affected units, Imaxeon Service Representative will be in contact to schedule an appointment to come and replace the main board. Imaxeon have established a prioritisation plan for the corrections which first addresses customers who have reported the problem and those who have the most critical medical diagnostic needs |
| Contact Information |
02 8845 4999 - Imaxeon Customer Support Team |