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Terminated

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.

FDA Recall Z-0373-2014 · Posted 2013-11-21

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeIYO
Date Initiated2013-10-11
Date Terminated2015-01-23
Product Quantity710

Reason for Recall

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.

Firm Action

An Urgent Medical Device Correction letter, dated 10/11/2013, was sent to 3 departments within the affected hospitals. The letter described the safety issue, and identified affected devices. The letter stated to reboot the scanner in an unresponsive /lock up condition. Also if the system is being used for an interventional procedure, the TEE probe should remain in the patient while system is rebooting. A GE healthcare service engineer will install a correction to affected devices.

Root Cause

Component change control

Distribution Pattern

Worldwide Distribution-USA (nationwide) and the countries of Algeria, Argentina, Australia, Austria, Belarus, Belgium, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Italy, Japan, Korea (Republic of), Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Malaysia, Netherlands, Norway, Oman, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K120201GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEMGe Vingmed Ultrasound AS · 2012-04-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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