Reported Sep 26, 2018 · Terminated
sterEOS workstation
EOS Imaging
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: EOS Imaging · 4 Ieme Etage · Paris, N/A · N/A
Is this the product you have?
- sterEOS workstation
- Lot codes and dates
- All software versions are impacted
- Amount recalled
- 17 units
Where it was sold
- Nationwide
Why it was recalled
3D projections may be incorrect when the pair of images used is a secondary capture generated from a series containing more than two images, where one of the images has been manually flipped. Projection errors may lead to errors in calculation of 3D clinical parameters when adjusting the position, size and shape of the 3D objects used. Incorrect clinical parameters can be a contributing factor in incorrect clinical decisions, or sub-optimal surgical interventions.
This product could cause temporary or reversible health problems — stop using it.
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