Company: GE Healthcare, LLC
Date of Enforcement Report:11/27/2013
Class ll:
PRODUCT
GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E9 incorporates a variety of electronic array transducers operating in linear, curved linear, sector/phased array or matrix array format, including two dedicated CW transducers and several real time 3D transducers. It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, LCD color video display and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability.
Recall Number Z-0373-2014
REASON
GE became aware of a potential safety issue due to a system slow down and system lock up associated with the software of Vivid E9 ultrasound system. During a critical procedure the Vivid E9 Scanner may gradually become unresponsive and eventually lock up, with the result that the vivid E9 Scanner must be rebooted.
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI on 10/11/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
710
DISTRIBUTION
Nationwide and Internationally
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