| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00877-1 |
| Product Name/Description |
Spacelabs Healthcare Integrated Module Housing (Used for accommodating additional modules to the patient monitor whenever needed)
Model Number: 91493
ARTG Number: 128789 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/08/2012 |
| Responsible Entity |
|
| Reason/Issue |
There is a potential failure of the Integrated Module Housing; causing the patient module parameters to drop off the monitor display or the patient module will fail to sign on when inserted into the housing. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Medtel is providing work around instructions to users to mitigate the issue until a permanent fix can be installed. |
| Contact Information |
03 8564 0806 - Medtel Regulatory Affairs |