Company:GE Healthcare, LLC
Date of Enforcement Report 2/20/2013
Class ll:
PRODUCT
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and accessories. Recall Number Z-0813-2013
REASON
GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor. These issues may occur when the Ethernet controller in the XPC823 CPU on the Dash and DashPort 2 motherboard functions intermittently. GE Healthcare has identified that these issues occur most often at sites with large Unity Network installations. It should be noted that the Dash 3000/4000/5000 patient monitor continues to monitor parameters and alarms as a stand-alone bedside with no issues.
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WA on 6/13/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
119,262
DISTRIBUTION
Nationwide and Internationally
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