| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00594-1 |
| Product Name/Description |
CARESCAPE Monitor B650
Software Versions: 1.1.12.26 or earlier
ARTG Number: 115304 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
29/05/2014 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has recently become aware of a potential safety issue due to possible sound loss associated with the CARESCAPE Monitor B650. When an external display is connected to the CARESCAPE Monitor B650 using a USB extender cable with an active USB hub, the system may experience a sound loss including alarm sounds from the patient monitor. This may occur if the external display is powered off and on during normal operation of the monitor. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE is advising their customers that this issue can be avoided by not switching the external display off and then switching it back on during normal monitor use and by not using a USB extender cable with active hub. If the sound loss occurs during normal operation of the monitor, users can enable the sounds back on by restarting the monitor. A software patch will be provided to correct this issue permanently. |
| Contact Information |
1800 659 465 - GE Healthcare National Call Centre |