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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-01109-1
Product Name/Description	CARESCAPE Monitor B850 (with software versions 1.0.12 and earlier) and CARESCAPE Monitor B650 (with software version 1.1.12 and earlier) ARTG Number: 115304
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	31/10/2013
Responsible Entity	GE Healthcare Australia Pty Ltd
Reason/Issue	Non-Invasive Blood Pressure (NIBP) - Auto-cycling not starting/stopping, NIBP measurement not performed if network time update occurs at same time, infants limits are incorrect. ECG- Wrong ECG bandwidth in E-PSM(P) or E-(P)RE(S)TN module. Changing primary ECG lead selection will not change primary measurement in PDM or TRAM. Central Monitor- A temporarily hidden alarm message will not reactivate if different alarm is acknowledged, audible alarm missing after broken network connection, ECG not shown on iCentral, standby doesn't end, & incorrect labelling on V leads. Ventilation Alarms- Incorrect display of Airway pressure in bed to bed view, spirometry alarm limits can't be changed. General- Alarm off issues in small parameter window, auto-discharge doesn't erase data, invasive pressure lables incorrect. TRAM -Missing service alarm Bed to bed view doesn't show highest ST value in S/5 network, missing remote alarm & AVOA alarm, monitor disconnect alarms not restored.
Recall Action	Recall for Product Correction
Recall Action Instructions	GE Healthcare is advising users of work around instructions to follow as an interim measure. GE is providing users with a laminated sheet summarising the work around instructions to keep near the affected units for easy reference until the software update is implemented to correct the issues. This action has been closed-out on 12/02/2016.
Contact Information	1800 659 465 - GE Healthcare National Call Centre