| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00030-1 |
| Product Name/Description |
Integra Camino Intracranial Pressure (ICP) Monitor and the Integra Licox PtO2 and Temperature Monitor
Integra Camino Intracranial Pressure (ICP) Monitor
Catalogue Number: CAM02
All serial numbers affected
Integra Licox PtO2 and Temperature Monitor
Catalogue Number: LCX02
All serial numbers affected
ARTG Number: 216915 and 217355 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/01/2016 |
| Responsible Entity |
|
| Reason/Issue |
The speakers in Camino ICP Monitors (CAM02) and the Licox PtO2 and Temperature Monitors (LCX02) may potentially malfunction. If this occurs, the monitors will stop providing an audible tone at start-up or at alarm points during use. Although unlikely, this may lead to central herniation that could potentially result in brain death or reversible ischemia; Moderate hypoxic brain injury; Elevation of ICP or decrease in PtO2. No reports of patient injury or adverse events have been received. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The affected units are to be returned to the manufacturer for a software upgrade to lower the input signal supplied to the speaker assembly. The monitor case will also be modified to increase the decibel level. |
| Contact Information |
1300 550 599 Integra Customer Service : |