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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00807-3
Product Name/Description Carescape Monitor B850, all software versions (mutliparameter patient monitor)

ARTG Number: 92726
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 GE Healthcare has recently become aware of potential issues with the Carescape Monitor B850 as outlined below:

1. Carescape Monitor B850 uDOM failure. It is possible that the Carescape Monitor B850 may enter into a constant book loop causing monitor to reboot continuously.

2. Carescape Monitor B850 unstable USB communication. When the USB cable is connected to the CPU or display is insecurely connected or faulty, the monitor may reboot. Reboot may also happen if the monitor display is continuously set on and off several times.

3. Carescape Monitor B850 remote printing issue with currently printing PRN 50 recorder. If the recorder PRN 50 is busy when the Carescape Monitor B850 sends a printing request, the printing may not be saved and therefore not printed.

4. Carescape Monitor B850 reboots due to an X server freeze.
Recall Action Recall for Product Correction
Recall Action Instructions GE Healthcare will be implementing a software and hardware correction.
Contact Information 1300 722 229 - National Service and Support Centre