| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01523-1 |
| Product Name/Description |
CARESCAPE R860 ventilators with software version 10SP05
Item number: 00840682102346
ARTG Number: 108358 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
19/12/2017 |
| Responsible Entity |
|
| Reason/Issue |
There is a potential for the display processor to experience an unexpected failure. If this failure occurs, the device screen will temporarily go blank and will then display an Error Code “EC01 XX”. The blank display results in loss of monitored data being displayed to the user. There have been no injuries reported as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is advising users that the system can continue to be used. In the event this issue occurs, an audible alarm will sound. Mechanical ventilation will continue at previous settings. A device restart is required to clear the alarm condition. Consider using appropriate alternative means of ventilation such as a self-inflating bag or another ventilator to prevent patient injury while restarting the device.
GE Healthcare will be implementing a software upgrade as a permanent correction.
This action has been closed out on the 16/11/2018. |
| Contact Information |
1800 659 465 - GE National Contact Centre |