Reported Nov 27, 2013 · Terminated
GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- 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.
- Lot codes and dates
- Serial numbers
710 of 710 codes
0000000VE941660000000VE941670000000VE941700000000VE941710000000VE941720000000VE941730000000VE941740000000VE941750000000VE941760000000VE941770000000VE941780000000VE941790000000VE941800000000VE941810000000VE941820000000VE941830000000VE941840000000VE941850000000VE941860000000VE941870000000VE941880000000VE941900000000VE941910000000VE941920000000VE941930000000VE941940000000VE941950000000VE941960000000VE941970000000VE941980000000VE941990000000VE942100000000VE942110000000VE942120000000VE942130000000VE942140000000VE942150000000VE942160000000VE942170000000VE942250000000VE942260000000VE942270000000VE942310000000VE942320000000VE942330000000VE942340000000VE942350000000VE942360000000VE942370000000VE942380000000VE942430000000VE942440000000VE942450000000VE942460000000VE942470000000VE942480000000VE942490000000VE942500000000VE942510000000VE94252
- Serial numbers
- Amount recalled
- 710
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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