Reported Apr 24, 2013 · Terminated
GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventional Imaging System.
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 Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventional Imaging System.
- Lot codes and dates
- Serial Number
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
- Serial Number
- Amount recalled
- 48
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
As part of GE Innova IQ table introduction, a label was designed to be affixed on the front Cover of the Gantry Pivot section. This safety label is missing on systems manufactured between March 2010 and July 2011. In the situation a staff member (doctor, nurse, operator, anesthetist, etc&) stands in the region between the C-arm gantry pivot and the head section of the table, there is a risk of co
This product could cause temporary or reversible health problems — stop using it.
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