| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01136-1 |
| Product Name/Description |
Spacelabs Healthcare Qube Compact Monitor (Multi parameter transportable patient monitor)
Serial Numbers:1390 - 000340, 1390 - 000339, 1390 - 000338 & 1390 - 000337
ARTG Number: 108755 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
There is a potential failure of the Qube Compact Monitor where the input power can fail even though the power source at the wall has not been interrupted. The monitor automatically goes into battery mode and functions normally, including the low battery alerts, until the batteries become depleted and the monitor turns off. In addition, there is the potential for the Qube Compact Monitor to fail to turn on. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
As an interim measure, Medtel is providing work around instructions to reduce the probability of occurrence. New hardware will be installed to permanently correct the issue as soon as possible. |
| Contact Information |
03 8564 0802 - Medtel Australia Regulatory Affairs |