Recall Z-0373-2014 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
GE Healthcare, LLC
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 transd
| Date | Nov 21, 2013 (initiated Oct 11, 2013) |
| Status | Terminated |
| 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. |
| 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120201 | GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM Ge Vingmed Ultrasound AS, Apr 19, 2012 |