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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00806-3
Product Name/Description Carescape Monitor B650 (Multi parameter patient monitor)

ARTG Number: 115304
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 8/08/2012
Responsible Entity GE Healthcare Australia Pty Ltd
Reason/Issue 1) SpO2 saturation limit alarm does not always activate when Nellcor SpO2 is used in PDM and Saturation Seconds is not switched ON.

2) When the CARESCAPE Monitor B650 is started the monitor may enter into a constant boot loop causing monitor to reboot continuously.

3) When the CARESCAPE Monitor B650 is connected to the Unity ID and information from a 3-lead ECG cable is transferred through DRI (S/5) network, the monitor may reboot.

4) Upgrading the software for CARESCAPE Monitor B650 may not update the software for power management card (PMC).

5) When the USB cable connected to the CARESCAPE Monitor B650 is insecurely connected or faulty and is able to move the monitor may reboot.

6) CARESCAPE Monitor B650 remote printing issue with currently printing PRN 50 recorder.

7) CARESCAPE Monitor B650 reboots due to an X server freeze. It may reboot when the monitor is viewed from CARESCAPE CIC Pro or when the printing is initiated from CARESCAPE CIC Pro.
Recall Action Recall for Product Correction
Recall Action Instructions GE Healthcare is providing users with work around instructions to mitigate the issue. A software and hardware update will be implemented to permanently fix the issue when available.
Contact Information 1300 722 229 - GE Healthcare National Service and Support Centre