CARESCAPE Monitor B850 (with software versions 1.0.12 and earlier) and CARESCAPE Monitor B650 (with software version 1.1.12 and earlier) 의 리콜

Recall

RC-2013-RN-01109-1

Class I

2013-10-31

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01109-1

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.

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.