Z-0373-2014Class II

GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily...

Name: Z-0373-2014 GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily...
Creator: GE Healthcare, LLC
Published: 2013-10-11
License: https://open.fda.gov/license/

GE Healthcare / initiated 2013-10-11 / Terminated / root cause: software

FDA source

GE Healthcare, LLC began a recall of 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... on 2013-10-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0373-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-11
Posted: 2013-11-21
Terminated: 2015-01-23
Recalling firm: GE Healthcare
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.
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
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.
Root cause tag: software
FDA root cause: Component change control
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.
Quantity in commerce: 710
Distribution: 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.
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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0373-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0373-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-21

Product code IYO

K120201Class IIGe Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS / cleared 2012-04-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)