Reported Mar 13, 2013 · Terminated
GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume…
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 Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume Analysis (Advantage Workstation 4.0) Volume Analysis (Advantage Workstation 3.1) Advantage Windows Volume Rendering Option is intended to provide fast, easy, volume visualization of three dimensional structures imaged with a computed tomography (CT) or magnetic resonance (MR) system. It is dedicated to clinical and diagnostic applications in radiology, surgery, and treatment planning.
- Lot codes and dates
- Not Available
293 of 293 codes
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
69 of 69 codes
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
- Amount recalled
- 363
Where it was sold
Why it was recalled
Incorrect views and measurements possible. GE Healthcare became aware of multiple potential safety issues involving the Advantage workstation, Volume Viewer Plus and Volume Analysis.
This product could cause temporary or reversible health problems — stop using it.
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