Reported Jan 1, 2014 · Terminated
steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The…
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 · 10 rue Mercoeur 4 Ieme Etage · Paris France, N/A · N/A
Is this the product you have?
- steroEOS
- Workstation with software versions
1.31.4 and 1.5 used in processing 3D
- X-ray images Product UsageThe sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images
- Lot codes and dates
- Software versions
1.31.4 and 1.5
- Software versions
- Amount recalled
- 36 units
Where it was sold
- Nationwide
Why it was recalled
Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation
This product could cause temporary or reversible health problems — stop using it.
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